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 Device Embedded In Tissue or Plaque (3165)

Event Date 12/13/2016

Event Type  Injury  

Manufacturer Narrative

The suspect device lot number was not provided; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Complaint source: this event was referred to indirectly in voluntary user medwatch number mw5066787.This report is to capture the previous device with the same issue that day.

Event Description

It was reported to boston scientific corporation that a capio slim was used during an unknown procedure on (b)(6) 2016.According to the complainant, during the procedure, the carrier detached and was not able to retrieved.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: 6303228
• MDR Text Key: 66555281
• Report Number: 3005099803-2017-00149
• Device Sequence Number: 1
• Product Code: FHQ
• UDI-Device Identifier: 08714729842224
• UDI-Public: (01)08714729842224(17)20191020(10)19868166
• 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: 01/10/2017

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 Model Number: M0068318261
• Device Catalogue Number: 831-826
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/10/2017
• Initial Date FDA Received: 02/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other