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 Consequences Or Impact To Patient (2199)

Event Date 05/30/2018

Event Type  Injury  

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

Note: this report pertains to one of three devices used during the same procedure.Refer to manufacturer report #3005099803-2018-01902 and 3005099803-2018-01900 for the other associated device information.It was reported to boston scientific corporation that three capio¿ slim devices were used during an anterior and posterior repair with biologic graft procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the carrier of the first two devices broke off.The carrier of the first device [mfr report #3005099803-2018-01899] broke in half, and the second one [mfr report #3005099803-2018-01902] broke off completely.The broken carriers were removed from the patient with the use of pickup forceps.For the third device used [mfr report #3005099803-2018-01900], the capio carrier and cage mechanism was reportedly stuck and would not retract.The procedure was completed with a different device.There were no patient complications reported as a result of these events.The patient's condition at the conclusion of the procedure was reported to be fine.

Manufacturer Narrative

A visual examination of the returned capio slim revealed that the carrier was broken.The broken section of the carrier was not returned by the customer.A functional examination of the device was not performed due to the device condition (carrier broken).A review of the device history record (dhr) indicated that the device met all material, assembly, and product specifications at the time of release to distribution.However, the investigation concluded that the root cause for this complaint is design product enhancement since a modification would improve performance, function or appearance of the product.Furthermore, a labeling review was performed and, from the information available, this device was used per the directions for use (dfu)/product label.There is an investigation open to address the issue of "carrier broken.".

Event Description

Note: this report pertains to one of three devices used during the same procedure.Refer to manufacturer report #3005099803-2018-01902 and 3005099803-2018-01900 for the other associated device information.It was reported to boston scientific corporation that three capio slim devices were used during an anterior and posterior repair with biologic graft procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the carrier of the first two devices broke off.The carrier of the first device [mfr report #3005099803-2018-01899] broke in half, and the second one [mfr report #3005099803-2018-01902] broke off completely.The broken carriers were removed from the patient with the use of pickup forceps.For the third device used [mfr report #3005099803-2018-01900], the capio carrier and cage mechanism was reportedly stuck and would not retract.The procedure was completed with a different device.There were no patient complications reported as a result of these events.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: 7623636
• MDR Text Key: 111819887
• Report Number: 3005099803-2018-01899
• Device Sequence Number: 1
• Product Code: FHQ
• UDI-Device Identifier: 08714729842224
• UDI-Public: 08714729842224
• 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,Followup
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2021
• Device Model Number: M0068318261
• Device Catalogue Number: 831-826
• Device Lot Number: 21872354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2018
• 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): Required Intervention