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 Device Embedded In Tissue or Plaque (3165)

Event Date 04/11/2016

Event Type  Injury  

Manufacturer Narrative

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¿ slim was used during a vaginal paravaginal cystocele repair with xenform graft procedure performed on (b)(6) 2016.According to the complainant, the endopelvic fascia was perforated at the sacrospinous process level and the "white line" (arcus tendineus fasciae pelvis - atfp) was cleaned off up to the pubic tubercle on both sides.The capio suture was used to deliver one suture through the right anterior "white line." the device appeared to fire normally, but upon removal, the bullet needle was found to be missing from the end of the suture.The physician felt a piece of metal when trying to locate the bullet needle inside the patient.This was extracted using kelly forceps and found to be an approximately 1cm long piece of the capio device (carrier).The suture bullet/needle was not palpable and they decided to leave it inside the patient.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.

Manufacturer Narrative

A visual examination of the returned capio (tm) slim revealed that the capio carrier was broken.This was likely due to a supplier manufacturing issue.The supplier has since completed an investigation to address this issue.A review of the device history record (dhr) was performed; no anomalies were noted.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¿ slim was used during a vaginal paravaginal cystocele repair with xenform graft procedure performed on (b)(6) 2016.According to the complainant, the endopelvic fascia was perforated at the sacrospinous process level and the "white line" (arcus tendineus fasciae pelvis - atfp) was cleaned off up to the pubic tubercle on both sides.The capio suture was used to deliver one suture through the right anterior "white line".The device appeared to fire normally, but upon removal, the bullet needle was found to be missing from the end of the suture.The physician felt a piece of metal when trying to locate the bullet needle inside the patient.This was extracted using kelly forceps and found to be an approximately 1 cm long piece of the capio device (carrier).The suture bullet/needle was not palpable and they decided to leave it inside the patient.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.

• 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: 6262351
• MDR Text Key: 65202840
• Report Number: 3005099803-2017-00038
• Device Sequence Number: 1
• Product Code: FHQ
• UDI-Device Identifier: 08714729842224
• UDI-Public: (01)08714729842224(17)20181014(10)0018517656
• 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: 12/30/2016

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: Physician
• Device Expiration Date: 10/14/2018
• Device Model Number: M0068318261
• Device Catalogue Number: 831-826
• Device Lot Number: 0018517656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/30/2016
• Initial Date FDA Received: 01/18/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2015
• 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
• Patient Age: 77 YR
• Patient Weight: 63