MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RADIAL JAW 4; FORCEPS, BIOPSY, NON-ELECTRIC

Model Number	M00513453
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Second physician in case: dr.(b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 pediatric biopsy forceps was used in the lung during a transbronchial biopsy procedure related to a right middle lobe cavitary lesion performed on (b)(6) 2019.During the procedure, a monarch robotic bronchoscope was inserted into the right middle lobe of the lungs.Once the bronchoscope reached the target, physician first used a non-bsc needle to acquire a sample of the nodule.After a few unsuccessful attempts, a non-bsc forceps was then used to attempt to acquire a sample but was still unsuccessful.The forceps was then replaced with the radial jaw 4 pediatric biopsy forceps.According to the physician, "i had taken somewhere between 8 and 10 biopsies and literally was on my last biopsy.I extended the forceps into the middle lobe, the technician opened the forceps and under fluoroscopy we were ready to take the last biopsy.When i asked her to close the forceps and then tried to take my biopsy i could not retract the forceps.Fluoroscopy revealed the jaws to be open.I asked the technician to close the jaws and they would not close.I then asked her to open the jaws and at that moment with my hand on the catheter i felt something snap.The jaws remained open and i was unable to withdraw the forceps despite a considerable amount of force.We did cut the proximal end of the forceps so that we could get the bronchoscope out of the patient.The patient was then moved to the operating room with my thoracic surgery colleague.Under general anesthesia and prepped for an emergency thoracotomy in the event of bleeding or airway perforation, she used extreme force to try to extract the forceps.The outer covering essentially came off leaving just the wires.The wires were then grasped and pulled to the point of fracturing loose from the jaws.The jaws were imbedded in the proximal aspect of the right middle lobe.This was not deep into the lung tissue.The jaws appeared to be stuck in an open position in a subsegmental airway of the right middle lobe and were not embedded directly in distal lung." the patient was then transferred to the overnight facility within the hospital.Two days later, a right middle lobe lobectomy procedure was performed to remove the jaw portion of the forceps and diseased tissue.Reportedly, the lobectomy went well, and the patient has since been discharged.
Additional Manufacturer Narrative
Block e1: second physician in case:(b)(6).Block h6: problem code 3191 captures the reportable event of surgery.Block h10: the complaint device was returned disassembled.The jacket was not returned complete.Visual analysis found the coil was stretched, and one of the pull wires is broken.The jaws, eyelet, needle/washer, clevis, and handle integrity were in good condition.Functional analysis could not be performed due to the condition of the returned device.The failure pull wire broken could be due to material fatigue after several uses, withdrawing the device, or while disassembling and manipulation of the device.Based on the event description and all compiled information, the most probable cause of the event is adverse event related to procedure, as factors or conditions related to the procedure likely could have affected its performance and its intended purpose.An investigation has been initiated to address this issue.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.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 pediatric biopsy forceps was used in the lung during a transbronchial biopsy procedure related to a right middle lobe cavitary lesion performed on (b)(6) 2019.During the procedure, a monarch robotic bronchoscope was inserted into the right middle lobe of the lungs.Once the bronchoscope reached the target, physician first used a non-bsc needle to acquire a sample of the nodule.After a few unsuccessful attempts, a non-bsc forceps was then used to attempt to acquire a sample but was still unsuccessful.The forceps was then replaced with the radial jaw 4 pediatric biopsy forceps.According to the physician, "i had taken somewhere between 8 and 10 biopsies and literally was on my last biopsy.I extended the forceps into the middle lobe, the technician opened the forceps and under fluoroscopy we were ready to take the last biopsy.When i asked her to close the forceps and then tried to take my biopsy i could not retract the forceps.Fluoroscopy revealed the jaws to be open.I asked the technician to close the jaws and they would not close.I then asked her to open the jaws and at that moment with my hand on the catheter i felt something snap.The jaws remained open and i was unable to withdraw the forceps despite a considerable amount of force.We did cut the proximal end of the forceps so that we could get the bronchoscope out of the patient.The patient was then moved to the operating room with my thoracic surgery colleague.Under general anesthesia and prepped for an emergency thoracotomy in the event of bleeding or airway perforation, she used extreme force to try to extract the forceps.The outer covering essentially came off leaving just the wires.The wires were then grasped and pulled to the point of fracturing loose from the jaws.The jaws were imbedded in the proximal aspect of the right middle lobe.This was not deep into the lung tissue.The jaws appeared to be stuck in an open position in a subsegmental airway of the right middle lobe and were not embedded directly in distal lung." the patient was then transferred to the overnight facility within the hospital.Two days later, a right middle lobe lobectomy procedure was performed to remove the jaw portion of the forceps and diseased tissue.Reportedly, the lobectomy went well, and the patient has since been discharged.

• Brand Name: RADIAL JAW 4
• Common Device Name: FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8680474
• Report Number: 3005099803-2019-02780
• Device Sequence Number: 13971315
• Product Code: FCL
• UDI-Device Identifier: 08714729790228
• UDI-Public: 08714729790228
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2019

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 Expiration Date: 09/20/2021
• Device Model Number: M00513453
• Device Catalogue Number: 1345S
• Device Lot Number: 0022687804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 07/16/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 08/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 86