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 Date 02/21/2018

Event Type  Injury  

Manufacturer Narrative

Device component code is related to device problem code for the problem of needle detachment.The voluntary user medwatch number is mw5075544.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 Description

This report pertains to three complaint devices used during the same procedure.Manufacturer report# 3005099803-2018-01005 pertains to the first capio device, manufacturer report#3005099803-2018-01006 pertains to the second capio device and manufacturer report# 3005099803-2018-01007 pertains to the third capio device.It was reported to boston scientific corporation that three capio slim devices were used during a sacrospinous fixation procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the capio devices were opened and not working properly.Four sutures had detached needles when used with the three capio devices.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
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7435045
• MDR Text Key: 105633828
• Report Number: 3005099803-2018-01006
• 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,health
• Type of Report: Initial
• Report Date: 03/20/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2020
• Device Model Number: M0068318261
• Device Catalogue Number: 831-826
• Device Lot Number: 0021522919
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/20/2018
• Initial Date FDA Received: 04/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other