MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) CAPIO¿; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	M0068312321
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/21/2016
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 device was used during a mesh placement procedure on (b)(6) 2016.According to the complainant, during the procedure, while suturing the sacrospinous ligament, the capio carrier broke off the device.The detached piece was "unretrievable" and left inside the patient.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
A visual examination of the returned capio revealed that the carrier detached and was not returned.The nitinol wire is out of its normal position, but has crimping marks indicating the crimping process was performed.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.A labeling review was performed and no anomalies were found.The review and analysis of all available information fails to indicate a root cause or probable root cause.Therefore, the root cause of this complaint is undeterminable.
Event or Problem Description
It was reported to boston scientific corporation that a capio device was used during a mesh placement procedure on (b)(6) 2016.According to the complainant, during the procedure, while suturing the sacrospinous ligament, the capio carrier broke off the device.The detached piece was "unretrievable" and left inside the patient.There were no patient complications reported as a result of this event.

• Brand Name: CAPIO¿
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 6243968
• Report Number: 3005099803-2017-00045
• Device Sequence Number: 13668610
• Product Code: GCJ
• UDI-Device Identifier: 08714729257622
• UDI-Public: (01)08714729257622(17)20190518(10)19225758
• 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): 12/21/2016

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: 05/18/2019
• Device Model Number: M0068312321
• Device Catalogue Number: 831-232
• Device Lot Number: 19225758
• 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: 12/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/11/2017
• Supplement Report FDA Received Date: 03/15/2017
• 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: Other