MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPTIFLEX; SNARE, FLEXIBLE

Model Number	M00562422
Medical Device Problem Codes	Use of Device Problem (1670); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a captiflex small oval flexible snare was used in the esophagus and bile duct to treat biliary stones during an endoscopic retrograde cholangiopancreatography (ercp) with stent removal and spyglass procedure performed on (b)(6) 2021.It was reported that during the procedure and inside the patient, the physician was attempting to remove an advanix plastic biliary stent from the patient with a captiflex snare.After he initially closed around the stent and pulled it, the snare loop completely broke off the catheter.The physician then advanced another snare and realized that the snare loop was still lodged in the distal end of the scope.He withdrew the scope and removed the snare piece.Also, no other visible issue was noted with the snare.The procedure was completed with a different snare.There was bleeding noticed after the scope was reinserted but the patient was on eliquis for blood; the device issue did not contribute to the patient's complication and the bleeding resolved on its own.The patient condition following the procedure was reported to be stable.Note: it was reported that the physician attempted to remove an advanix plastic biliary stent from the patient with a captiflex snare.However, per the instructions for use (ifu), the single-use polypectomy snares are indicated for use in the removal and cauterization of diminuitive polyps, sessile polyps, and pedunculated polyps.
Additional Manufacturer Narrative
Block h6: problem code a0501 captures the reportable event of snare loop detached.Block h10: investigation results a captiflex small oval flexible snare was received for analysis.Visual inspection of the returned device revealed that the loop was detached from the cannula and was not returned.Also, evidence of crimping marks were noted on the device which showed that the process was done in the unit and it ensured that the components were attached.No other issues were noted.The reported complaints of "loop failure to capture/remove foreign body" and "loop detachment of device or device component" were confirmed.The reported complaint of misuse was also confirmed confirmed as per the complaint and ifu (instructions for use) information.The reported complaint of "hemorrhage, minor" was unable to be confirmed since the alleged issue is related to patient condition.This investigation is assigned a conclusion code of cause traced to intentional off-label, unapproved, or contraindicated use.This code was selected as the most probable complaint cause based on the information available and the condition of the returned device.The product record review confirmed that this is not a new failure type and the risk is anticipated.There is no evidence of a manufacturing or design issue which could have caused the complaint.The use of this captiflex - snares device is indicate for the removal and or cauterization of polyps.As per the ifu, it states that "the captiflex - snares is indicated for use endoscopically for the removal and or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the gastrointestinal tract.".It was stated in the event description that the physician was attempting to remove an advanix plastic biliary stent from patient with captiflex snare.It is most likely that the inadequate use compromised the device performance.As a result, the loop detached from the cannula and loop retraction problem.From the complaint information it is noted that the device was being used outside of its labelled indications for use.This may have contributed to the complaint incident.The hemorrhage, minor is assigned a conclusion code known inherent risk of device.This conclusion code was selected as hemorrhage, minor is listed in captiflex - snares instructions for use (ifu) as a potential complication that may result from the snare piece removal during the procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.A labeling review was performed and, from the information available, the device was being used outside of its labelled indications for use which may have contributed to the complaint incident.
Event or Problem Description
It was reported to boston scientific corporation that a captiflex small oval flexible snare was used in the esophagus and bile duct to treat biliary stones during an endoscopic retrograde cholangiopancreatography (ercp) with stent removal and spyglass procedure performed on (b)(6), 2021.It was reported that during the procedure and inside the patient, the physician was attempting to remove an advanix plastic biliary stent from the patient with a captiflex snare.After he initially closed around the stent and pulled it, the snare loop completely broke off the catheter.The physician then advanced another snare and realized that the snare loop was still lodged in the distal end of the scope.He withdrew the scope and removed the snare piece.Also, no other visible issue was noted with the snare.The procedure was completed with a different snare.There was bleeding noticed after the scope was reinserted but the patient was on eliquis for blood; the device issue did not contribute to the patient's complication and the bleeding resolved on its own.The patient condition following the procedure was reported to be stable.Note: it was reported that the physician attempted to remove an advanix plastic biliary stent from the patient with a captiflex snare.However, per the instructions for use (ifu), the single-use polypectomy snares are indicated for use in the removal and cauterization of diminuitive polyps, sessile polyps, and pedunculated polyps.

• Brand Name: CAPTIFLEX
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11778438
• Report Number: 3005099803-2021-02039
• Device Sequence Number: 19744638
• Product Code: FDI
• UDI-Device Identifier: 08714729501657
• UDI-Public: 08714729501657
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K131700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/08/2023
• Device Model Number: M00562422
• Device Catalogue Number: 6242-40
• Device Lot Number: 0026485605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1