MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPIO CL; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	M0068311350
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a capio cl device was used during a suburethral sling placement with anterior and posterior repair procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the device was correctly fired once.However, when deploying the capio device on the patient's left side, the dart detached from the suture.Reportedly, there were two darts that detached from the sutures.An x-ray was subsequently performed and the radiologist could not locate any dart inside the patient.The procedure was completed with another capio cl device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.
Event or Problem Description
It was reported to boston scientific corporation that a capio cl device was used during a suburethral sling placement with anterior and posterior repair procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the device was correctly fired once.However, when deploying the capio device on the patient's left side, the dart detached from the suture.Reportedly, there were two darts that detached from the sutures.An x-ray was subsequently performed and the radiologist could not locate any dart inside the patient.The procedure was completed with another capio cl device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.
Additional Manufacturer Narrative
Blocks f10 and h6: device code 2907 captures the reportable event of dart detachment.Block h10: visual analysis showed that the cage was bent and no remains of the dart were found inside the cage.Functional analysis revealed that the carrier was actuated three times and it could be extended and retracted without any issues and no conditions that could contribute to the reported issue were found.However, it was actuated with the suture and the needle does not entered in the slot cage.A review of the device history record (dhr) indicated that the device met all material, assembly, and product specifications at the time of release to distribution.The investigation determines that the most probable cause is adverse event related to procedure, since the issue occurred during the procedure and there is no evidence that the device had influence on it.

• Brand Name: CAPIO CL
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8848465
• Report Number: 3005099803-2019-03780
• Device Sequence Number: 2515556
• Product Code: GCJ
• UDI-Device Identifier: 08714729516545
• UDI-Public: 08714729516545
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K973415
• 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): 08/26/2019

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: 04/12/2022
• Device Model Number: M0068311350
• Device Catalogue Number: 831-135
• Device Lot Number: 0023640358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 08/01/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 08/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR