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

Model Number M0068318250

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/05/2017

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to report lot number; therefore the manufacture date and expiration date are unknown.However, the complainant stated that the device was used prior to the expiration date.Initial reporter: additional contact: dr.(b)(6).(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.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

It was reported to boston scientific corporation that a capio¿ slim was used during a bladder suspension procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the capio carrier detached inside the patient.An x-ray was taken and the capio carrier was found in the patient's abdomen.Reportedly, the detached piece was left in the patient as removing it could do more harm than good.The procedure was completed with another capio¿ slim.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

A visual examination of the returned capio slim revealed no visual failure.The carrier was actuated three times and it extended and retracted without any issues.Also, it was actuated (deployed) three times with the suture and the needle entered in the slot without any issues.The investigation concluded that the device showed no evidence of either the alleged issue or any defect that could have contributed to the event reported.Therefore, the complaint is not confirmed.

Event Description

It was reported to boston scientific corporation that a capio¿ slim was used during a bladder suspension procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the capio carrier detached inside the patient.An x-ray was taken and the capio carrier was found in the patient's abdomen.Reportedly, the detached piece was left in the patient as removing it could do more harm than good.The procedure was completed with another capio¿ slim.The patient's condition at the conclusion of the procedure was reported to be stable.Additional information received on (b)(6) 2018.After deployment of the capio device, the needle detached from the suture.The capio carrier did not detach.The needle was left inside the patient.

• 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: 7160057
• MDR Text Key: 96331221
• Report Number: 3005099803-2017-03796
• Device Sequence Number: 1
• Product Code: FHQ
• UDI-Device Identifier: 08714729838005
• UDI-Public: 08714729838005
• 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: 12/05/2017

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 Model Number: M0068318250
• Device Catalogue Number: 831-825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 01/03/2018
• Supplement Dates Manufacturer Received: 01/03/2018
• Supplement Dates FDA Received: 01/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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