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

Model Number	M00513441
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 gastro-pediatric biopsy forceps was used in the right lower lobe of the lungs during a pleural biopsy of carcinomatous pleurisy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the forceps was used to performed pleural biopsy on a lesion about fifteen times.The scope was then turned over to another lesion for another biopsy; however, the handle of the forceps felt hard when actuating.Upon closing the forceps, the pull wire broke and detached into the patient.A non-bsc forceps was used to remove the detached pull wire, and the procedure was completed.There was no patient complications as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 gastropediatric biopsy forceps was used in the right lower lobe of the lungs during a pleural biopsy of carcinomatous pleurisy procedure performed on (b)(6) 2019 according to the complainant, during the procedure, the forceps was used to performed pleural biopsy on a lesion about fifteen times.The scope was then turned over to another lesion for another biopsy; however, the handle of the forceps felt hard when actuating.Upon closing the forceps, the pull wire broke and detached into the patient.A non-bsc forceps was used to remove the detached pull wire, and the procedure was completed.There was no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: device code 1069 captures the reportable event of pull wire detached.Block h10: visual analysis of the returned radial jaw 4 biopsy forceps found the pull wires were broken.The broken sections were inspected under magnification and no smooth surfaces were noted suggesting that this condition was not generated due to mechanical cut.Based on the event description, the device was used for pleural biopsy of carcinomatous pleurisy (lungs location).After reviewing the directions for use (dfu) there is a specific device for biopsies of the lungs and the used device in this case is for gastropediactric use.According to the product analysis performed, the failure pull wire broken, could have been generated during the preparation of the device or by manipulation during procedure.Additionally, during the manufacturing process, the units are 100% inspected in order to avoid the failures reported.Therefore, the most probable root cause is adverse event related to 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.

• 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: 8636062
• Report Number: 3005099803-2019-02606
• Device Sequence Number: 1845446
• Product Code: FCL
• UDI-Device Identifier: 08714729789918
• UDI-Public: 08714729789918
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2019

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: 01/28/2020
• Device Model Number: M00513441
• Device Catalogue Number: 1344
• Device Lot Number: 0020220463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Initial Date Received by Manufacturer: 04/26/2019
• Supplement Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 05/23/2019
• Supplement Report FDA Received Date: 07/15/2019
• 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: Required Intervention