MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION HEDGEHOG; ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE

Model Number	SBD-228-50
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to report the lot number; therefore, the manufacture date is unknown.This is a non-sterile device with no expiration date.Block h6: imdrf patient code e1906 captures the reportable event of unspecified infection.Imdrf device code a150208 captures the reportable event of entrapment of device.
Event or Problem Description
Note: this report pertains to the one hedgehog double-end brush used during scope cleaning and prior procedure retained in the scope.Refer to manufacturer report# 3005099803-2025-02766 for the hedgehog double-end brush (device malfunction report) and for the hedgehog double-end brush (serious injury report).It was reported to boston scientific corporation that a hedgehog double-end brush was used during a scope cleaning on (b)(6) 2025.During scope cleaning, the tip of the brush broke off and remained lodged inside the bronchoscope.The tech was cleaning and did not notice the broken brush until the reprocessing was finished.The bronchoscope was put through the oer (olympus endoscope preprocessor) machine and nothing was detected either.The scope was then hung clean and was used onto the next patient.During set up for the case they experienced no problems with the scope.Then, the tip of the brush that was lodged inside the bronchoscope, ended up falling inside the patient.In the physician's opinion, the patient developed an infection and required a follow-up procedure to remove the brush that had been left inside.Reportedly, the physician was not sure why he missed the broken brush and there were no attempts made to retrieved it during the initial bronchoscopy.Therefore, an additional procedure was performed to remove the device successfully using a rescue forceps.There were no patient complications during the retrieval, and it is unknown what was done to treat the patient infection, post initial bronchoscopy procedure.The patient's condition at the conclusion of the procedure was reported to be "fully recovered".
Additional Manufacturer Narrative
Additional information: block a2 (age at time of event and unit of measure - age), block a3a (sex), block a3b (gender), b5 (describe event or problem) and b7 (other relevant history).Block d4, h4: the complainant was unable to report the lot number; therefore the manufacture date is unknown.This is a non-sterile device with no expiration date.Block h6: imdrf patient code e1906 captures the reportable event of unspecified infection.Imdrf device code a150208 captures the reportable event of entrapment of device.Block h11: bronchoscopy procedure on (b)(6) done at (b)(6) hospital physician dr.(b)(6).Correction to block b3 (date of event).Correction to block e1 (physician's first name and last name).
Event or Problem Description
Note: this report pertains to the one hedgehog double-end brush used during scope cleaning and prior procedure retained in the scope.Refer to manufacturer report# 3005099803-2025-02766 for the hedgehog double-end brush (device malfunction report) and for the hedgehog double-end brush (serious injury report).It was reported to boston scientific corporation that a hedgehog double-end brush was used during a scope cleaning on may 27, 2025.During scope cleaning, the tip of the brush broke off and remained lodged inside the bronchoscope.The tech was cleaning and did not notice the broken brush until the reprocessing was finished.The bronchoscope was put through the oer (olympus endoscope reprocessor) machine and nothing was detected either.The scope was then hung clean and was used onto the next patient.During set up for the case they experienced no problems with the scope.Then, the tip of the brush that was lodged inside the bronchoscope, ended up falling inside the patient.In the physician's opinion, the patient developed an infection and required a follow-up procedure to remove the brush that had been left inside.Reportedly, the physician was not sure why he missed the broken brush and there were no attempts made to retrieved it during the initial bronchoscopy.Therefore, an additional procedure was performed to remove the device successfully using a rescue forceps.There were no patient complications during the retrieval, and it is unknown what was done to treat the patient infection, post initial bronchoscopy procedure.The patient's condition at the conclusion of the procedure was reported to be "fully recovered".Additional information was received on june 18, 2025: the patient underwent an inpatient bronchoscopy procedure on (b)(6) 2025.The patient had a bronchoalveolar lavage (bal).Reportedly, no fluoroscopy was required.On (b)(6) 2025; the patient had a follow up chest x-ray (cxr) and computed tomography (ct) which revealed a metallic object in the left lower lobe.The patient had another bronchoscopy procedure to retrieve the foreign object on (b)(6) 2025, which they confirmed that it was a boston scientific hedgehog cleaning brush.
Additional Manufacturer Narrative
Additional information received on june 18, 2025: block a2 (age at time of event and unit of measure - age), block a3a (sex), block a3b (gender), b5 (describe event or problem) and b7 (other relevant history).Additional information received on july 23, 2025: block b5 (describe event or problem) and b7 (other relevant history).Block d4, h4: the complainant was unable to report the lot number; therefore the manufacture date is unknown.This is a non-sterile device with no expiration date.Block g4: medwatch report#: (b)(4).Block h6: imdrf device code a150208 captures the reportable event of entrapment of device.Block h11: bronchoscopy procedure on (b)(6) done at (b)(6) hospital.Physician dr.(b)(6).Correction to block b3 (date of event).Correction to block e1 (physician's first name and last name).Correction to block h6 (patient codes).
Event or Problem Description
Note: this report pertains to the one hedgehog double-end brush used during scope cleaning and prior procedure retained in the scope.Refer to manufacturer report# 3005099803-2025-02766 for the hedgehog double-end brush (device malfunction report) and 3005099803-2025-02767 for the hedgehog double-end brush (serious injury report).It was reported to boston scientific corporation that a hedgehog double-end brush was used during a scope cleaning on (b)(6) 2025.During scope cleaning, the tip of the brush broke off and remained lodged inside the bronchoscope.The tech was cleaning and did not notice the broken brush until the reprocessing was finished.The bronchoscope was put through the oer (olympus endoscope reprocessor) machine and nothing was detected either.The scope was then hung clean and was used onto the next patient.During set up for the case they experienced no problems with the scope.Then, the tip of the brush that was lodged inside the bronchoscope, ended up falling inside the patient.In the physician's opinion, the patient developed an infection and required a follow-up procedure to remove the brush that had been left inside.Reportedly, the physician was not sure why he missed the broken brush and there were no attempts made to retrieved it during the initial bronchoscopy.Therefore, an additional procedure was performed to remove the device successfully using a rescue forceps.There were no patient complications during the retrieval, and it is unknown what was done to treat the patient infection, post initial bronchoscopy procedure.The patient's condition at the conclusion of the procedure was reported to be "fully recovered".Additional information was received on july 23, 2025: the patient was admitted in (b)(6) 2025 for dyspnea (shortness of breath) and hypoxia (low oxygen saturation in the blood).The physician decided to do a bronchoalveolar lavage (bal) procedure to rule out pneumocystis jiroveci pneumonia (pjp).The procedure was performed (b)(6) 2025.The patient was already requiring 4-6l o2 by nasal cannula prior to the procedure.The patient was in the supine position and the induction of anesthesia was difficult.The initial plan was to use laryngeal mask anesthesia (lma) though the patient developed laryngospasm, and endotracheal intubation was required.There was also difficulty with iv access prior to the insertion of the bronchoscope, and the examination was brief due to the patient experiencing hypotension.Reportedly the bronchoscopy itself went very smoothly.The scope was advanced to the left lower lobe of the lungs of patient, and visualization was reported to be very good.There was no resistance felt during the instillation of the lavage fluid through the working channel of the scope.The scope was functioning normally, with no noticeable alteration in suction prior to the procedure.No fluoroscopy was not used for that procedure.No foreign body (brush tip) was identified during the procedure.There were no attempts made to retrieve it during the initial bronchoscopy as they were unaware that the brush was inside of the patient.The bal fluid was positive for pjp and the patient rapidly improved after initiation of appropriate antibiotic treatment; oxygen was weaned off shortly thereafter.The patient was successfully discharged on (b)(6) 2025.Two months later, on (b)(6) 2025 the patient underwent a second bronchoscopy procedure after a routine follow-up chest x-ray and ct scan on (b)(6) 2025 revealed a metallic object located in the left lower lobe (lll) of the lungs.This procedure was performed to retrieve the foreign body.A little white ball was identified in the airway lumen and was retrieved with forceps.Initially, it was difficult to discern what it was, though after it was soaked in saline, the fragment of the brush was confirmed.It was identified as the tip of a bsc hedgehog cleaning brush.Per the bsc rep, the patient had 3 sets of cultures done and they have all came back with negative findings.There were no complications during this retrieval procedure and the brush was successfully removed from the patient.The airway in that area and distally appeared normal.Per the physician, the patient did well post procedure and had fully recovered.The facility had reported that there were some site and procedure changes in progress, which included more education on scope reprocessing.
Event or Problem Description
Note: this report pertains to the one hedgehog double-end brush used during scope cleaning and prior procedure retained in the scope.Refer to manufacturer report# 3005099803-2025-02766 for the hedgehog double-end brush (device malfunction report) and 3005099803-2025-02767 for the hedgehog double-end brush (serious injury report).It was reported to boston scientific corporation that a hedgehog double-end brush was used during a scope cleaning on may 27, 2025.During scope cleaning, the tip of the brush broke off and remained lodged inside the bronchoscope.The tech was cleaning and did not notice the broken brush until the reprocessing was finished.The bronchoscope was put through the oer (olympus endoscope reprocessor) machine and nothing was detected either.The scope was then hung clean and was used onto the next patient.During set up for the case they experienced no problems with the scope.Then, the tip of the brush that was lodged inside the bronchoscope, ended up falling inside the patient.In the physician's opinion, the patient developed an infection and required a follow-up procedure to remove the brush that had been left inside.Reportedly, the physician was not sure why he missed the broken brush and there were no attempts made to retrieved it during the initial bronchoscopy.Therefore, an additional procedure was performed to remove the device successfully using a rescue forceps.There were no patient complications during the retrieval, and it is unknown what was done to treat the patient infection, post initial bronchoscopy procedure.The patient's condition at the conclusion of the procedure was reported to be "fully recovered".Additional information was received on july 23, 2025: the patient was admitted in (b)(6) 2025 for dyspnea (shortness of breath) and hypoxia (low oxygen saturation in the blood).The physician decided to do a bronchoalveolar lavage (bal) procedure to rule out pneumocystis jiroveci pneumonia (pjp).The procedure was performed (b)(6) 2025.The patient was already requiring 4-6l o2 by nasal cannula prior to the procedure.The patient was in the supine position and the induction of anesthesia was difficult.The initial plan was to use laryngeal mask anesthesia (lma) though the patient developed laryngospasm, and endotracheal intubation was required.There was also difficulty with iv access prior to the insertion of the bronchoscope, and the examination was brief due to the patient experiencing hypotension.Reportedly the bronchoscopy itself went very smoothly.The scope was advanced to the left lower lobe of the lungs of patient, and visualization was reported to be very good.There was no resistance felt during the instillation of the lavage fluid through the working channel of the scope.The scope was functioning normally, with no noticeable alteration in suction prior to the procedure.No fluoroscopy was not used for that procedure.No foreign body (brush tip) was identified during the procedure.There were no attempts made to retrieve it during the initial bronchoscopy as they were unaware that the brush was inside of the patient.The bal fluid was positive for pjp and the patient rapidly improved after initiation of appropriate antibiotic treatment; oxygen was weaned off shortly thereafter.The patient was successfully discharged on (b)(6) 2025.Two months later, on (b)(6) 2025 the patient underwent a second bronchoscopy procedure after a routine follow-up chest x-ray and ct scan on (b)(6) 2025 revealed a metallic object located in the left lower lobe (lll) of the lungs.This procedure was performed to retrieve the foreign body.A little white ball was identified in the airway lumen and was retrieved with forceps.Initially, it was difficult to discern what it was, though after it was soaked in saline, the fragment of the brush was confirmed.It was identified as the tip of a bsc hedgehog cleaning brush.Per the bsc rep, the patient had 3 sets of cultures done and they have all came back with negative findings.There were no complications during this retrieval procedure and the brush was successfully removed from the patient.The airway in that area and distally appeared normal.Per the physician, the patient did well post procedure and had fully recovered.The facility had reported that there were some site and procedure changes in progress, which included more education on scope reprocessing.
Additional Manufacturer Narrative
Correction: user medwatch report number linked in section h10.Block h10 medwatch report#: (b)(4).

• Brand Name: HEDGEHOG
• Common Device Name: ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): CHANGZHOU TEMEIRUI MEDICAL; building 34 no 249; middle liangchan; changzhou, 100 21320 0; CH 213200
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22240783
• Report Number: 3005099803-2025-02767
• Device Sequence Number: 9098548
• Product Code: MNL
• UDI-Device Identifier: 00816849010083
• UDI-Public: (01)00816849010083
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SBD-228-50
• Device Catalogue Number: 60252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 06/18/2025; 07/09/2025; 10/07/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 07/14/2025; 08/06/2025; 10/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male