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 Known Impact Or Consequence To Patient (2692)

Event Date 05/07/2018

Event Type  Injury  

Manufacturer Narrative

Device component code is related to device problem code for the problem of needle detachment.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

This report pertains to one of two devices used during the same procedure.Refer to manufacturer report #3005099803-2018-01728 for the other associated device information.It was reported to boston scientific corporation that two capio¿ opc devices were used during a procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the first capio device (mfr report #3005099803-2018-01727) sheared the suture and they almost lost the dart inside the patient.Reportedly, they then tested the capio device outside the patient and revealed a misaligned carrier.They opened a second device (mfr report #3005099803-2018-01728) and the same issue occurred.The procedure was completed with another of the same capio¿ opc.There was no apparent harm done to the patient.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

Manufacturer Narrative

Analysis of the returned capio opc device revealed that the cage was bent.The carrier was able to extend and retract without issues.A functional evaluation deploying a suture could not be performed due to the cage condition - cage bent, consequently not confirming the reported complaint.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

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report #3005099803-2018-01728 for the other associated device information.It was reported to boston scientific corporation that two capio¿ opc devices were used during a procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the first capio device (mfr report #3005099803-2018-01727) sheared the suture and they almost lost the dart inside the patient.Reportedly, they then tested the capio device outside the patient and revealed a misaligned carrier.They opened a second device (mfr report #3005099803-2018-01728) and the same issue occurred.The procedure was completed with another of the same capio¿ opc.There was no apparent harm done to the patient.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.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
• MDR Report Key: 7580910
• MDR Text Key: 110445056
• Report Number: 3005099803-2018-01727
• Device Sequence Number: 1
• Product Code: FHQ
• UDI-Device Identifier: 08714729257615
• UDI-Public: 08714729257615
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• 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: 09/19/2018
• Date Manufacturer Received: 10/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention