MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) CAPIO¿ SLIM; HOLDER, NEEDLE, GASTROENTEROLOGIC

Model Number M0068318261

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 Description

It was reported to boston scientific corporation that a capio¿ slim was used during a sacrospinous ligament procedure performed on an unknown procedure date.According to the complainant, during the procedure, the dart detached from the suture after deploying the suture through the right sacrospinous ligament, ¿possibly due to too much stress on the suture.¿ reportedly, the dart appeared to be inside the capio device.The procedure was completed with another capio¿ slim.There were no patient complications reported as a result of this event.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.

Manufacturer Narrative

An analysis of the returned device revealed that the device does not have any visual failure and the carrier was actuated three times and it extended and retracted without any issues.Also, it was actuated (deployed) three times with the suture and the dart entered in the slot without any issues, consequently not confirming the reported complaint.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.Based on all gathered information and investigation results, there is no evidence of the alleged issue.Therefore, the reported issue was unable to be confirmed.

Event Description

It was reported to boston scientific corporation that a capio¿ slim was used during a sacrospinous ligament procedure performed on an unknown procedure date.According to the complainant, during the procedure, the dart detached from the suture after deploying the suture through the right sacrospinous ligament, ¿possibly due to too much stress on the suture.¿ reportedly, the dart appeared to be inside the capio device.The procedure was completed with another capio¿ slim.There were no patient complications reported as a result of this event.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.

• Brand Name: CAPIO¿ SLIM
• Type of Device: HOLDER, NEEDLE, GASTROENTEROLOGIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 7584532
• MDR Text Key: 110578543
• Report Number: 3005099803-2018-01805
• Device Sequence Number: 1
• Product Code: FHQ
• UDI-Device Identifier: 08714729842224
• UDI-Public: 08714729842224
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2021
• Device Model Number: M0068318261
• Device Catalogue Number: 831-826
• Device Lot Number: 0021664813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Date Manufacturer Received: 06/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1