MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH CAPIO¿; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	M0068312321
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/21/2016
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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a capio¿ was used during an unknown procedure on (b)(6) 2016.According to the complainant, during the procedure, the needle detached from the suture inside the patient.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.
Additional Manufacturer Narrative
A visual examination of the returned capio¿ device has the cage detached.The suture was loaded in the carrier and extends and retracts without any problem.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.The investigation concluded that this complaint is associated with a product that meets the design and manufacture specifications but due to anatomical/procedural factors encountered during the procedure, performance of the device was limited.The most probable root cause classification is operational context.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a capio¿ was used during an unknown procedure on (b)(6) 2016.According to the complainant, during the procedure, the needle detached from the suture inside the patient.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.

• Brand Name: CAPIO¿
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; propark free zone; marlborough MA 01752
• MDR Report Key: 6155282
• Report Number: 3005099803-2016-03772
• Device Sequence Number: 955092
• Product Code: GCJ
• UDI-Device Identifier: 08714729257622
• UDI-Public: (01)08714729257622(17)20190617(10)0019335465
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K932553
• 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): 11/21/2016

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: 06/17/2019
• Device Model Number: M0068312321
• Device Catalogue Number: 831-232
• Device Lot Number: 0019335465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/08/2016
• Supplement Report FDA Received Date: 02/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1