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

Model Number M0068318261

Device Problems Tear, Rip or Hole in Device Packaging (2385); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

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 # 3005099803-2018-01974 and 3005099803-2018-01976 for the other associated device information.It was reported to boston scientific corporation that three capio¿ slim devices were used received and unpacked on (b)(6) 2018.According to the complainant, during unpacking, holes in the inner packages of the devices were observed and devices were reported to be no longer sterile.It was also reported that there was no physician or patient involved.The procedure was completed with another capio¿ slim.

Manufacturer Narrative

A visual examination of the returned capio¿ slim device revealed that an opened pouch of capio was returned for analysis.The pouch had a hole in the back section.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.The investigation concluded that the most probable cause for this complaint is handling damage because it is possible that the way in which the device was handled and manipulated during shipping an external factor could have contributed to the failure found.

Event Description

Note: this report pertains to one of three devices used during the same procedure.Refer to manufacturer report # 3005099803-2018-01974 and 3005099803-2018-01976 for the other associated device information.It was reported to boston scientific corporation that three capio¿ slim devices were used received and unpacked on (b)(6) 2018.According to the complainant, during unpacking, holes in the inner packages of the devices were observed and devices were reported to be no longer sterile.It was also reported that there was no physician or patient involved.The procedure was completed with another capio¿ slim.

• 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: 7625535
• MDR Text Key: 111903568
• Report Number: 3005099803-2018-01975
• 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,Followup
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2020
• Device Model Number: M0068318261
• Device Catalogue Number: 831-826
• Device Lot Number: 20417302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Date Manufacturer Received: 07/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1