MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) DISPOSABLE SUTURE PLACEMENT SYSTEM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number UNK55

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/24/2018

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Device component code is related to device problem code for the problem of needle detachment.The complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.The voluntary user medwatch number is mw5077142.

Event Description

It was reported to boston scientific corporation that a capio device was used during a procedure performed on (b)(6) 2018 according to the complainant, during the procedure, upon deployment of the capio device on the patient's right side, the dart detached and got stuck in the periosteum of the pubic bone.They then opened the area and the retropubic space but they were unable to retrieve the dart.An op x-ray on the pelvic floor was performed to locate the dart and the dart was shown around the right side of the pubic bone.Several dissection performed in an attempt to retrieve the dart, but they were still unable to retrieve the dart.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.

• Brand Name: DISPOSABLE SUTURE PLACEMENT SYSTEM
• 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: 7623603
• MDR Text Key: 111819958
• Report Number: 3005099803-2018-01879
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K932553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 05/29/2018

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 Model Number: UNK55
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/29/2018
• 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
• Patient Outcome(s): Required Intervention