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

Model Number M0068318250

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/16/2017

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.(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 Description

Note: this report pertains to the second of two devices used during the same procedure.Associated manufacturer report #3005099803-2017-00943 pertains to the first device.It was reported to boston scientific corporation that a capio¿ slim was used during a sacrospinous fixation procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the carrier broke off/separated from the capio device while the device was outside the patient.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• 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: 6517999
• MDR Text Key: 73567446
• Report Number: 3005099803-2017-01161
• Device Sequence Number: 1
• Product Code: FHQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/04/2017

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
• Device Operator: Health Professional
• Device Model Number: M0068318250
• Device Catalogue Number: 831-825
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2017
• Initial Date FDA Received: 04/25/2017
• 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