MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) CAPIO¿; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number M0068311251

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2018

Event Type  Injury  

Manufacturer Narrative

(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

It was reported to boston scientific corporation that a capio¿ was used during a pelvic floor prolapse procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the dart detached from the suture during actuation of the device.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.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.

Manufacturer Narrative

An examination of the returned capio revealed that the cage bent and this condition could contribute to the reported failure, so the device condition was consistent with the reported complaint- the dart detached from the suture.Additionally, the carrier was able to extend and retract without issues.However, it failed deploying a suture due to the cage condition.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 this complaint is associated with a product that meets the design and manufacture specifications but due to anatomical/procedural factors encountered during the procedure, performance of the device was limited.The most probable root cause classification is operational context.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu)/product label.).

Event Description

It was reported to boston scientific corporation that a capio was used during a pelvic floor prolapse procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the dart detached from the suture during actuation of the device.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.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.

• Brand Name: CAPIO¿
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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: 7375065
• MDR Text Key: 103609766
• Report Number: 3005099803-2018-00698
• Device Sequence Number: 1
• Product Code: FHQ
• UDI-Device Identifier: 08714729257615
• UDI-Public: 08714729257615
• 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: 02/27/2018

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: 12/19/2020
• Device Model Number: M0068311251
• Device Catalogue Number: 831-125
• Device Lot Number: 21538405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2018
• Initial Date FDA Received: 03/27/2018
• Supplement Dates Manufacturer Received: 04/16/2018
• Supplement Dates FDA Received: 05/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2017
• 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