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 02/07/2017

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¿ slim was used during an anterior prolapse repair using capio procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the needle detached when trying to apply the through the sacrospinous ligament.It became dislodged inside the patient and he was not able to retrieve.The procedure was completed with another capio¿ slim.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 stable.

Manufacturer Narrative

Two capio devices were returned; one was the complaint device, the other was the one used to complete the procedure.Visual examination of the returned two capio devices revealed that neither device has any visual failure.Functional examination revealed that each devices' carrier was actuated three times and it extended and retracts without any problem.Also, it was actuated (deployed) three times with the suture and the needle entered in the slot.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 was unable to confirm the reported event; therefore the most probable root cause is "not confirmed".However, an investigation addressing this issue is in progress.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 an anterior prolapse repair using capio procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the needle detached when trying to apply the through the sacrospinous ligament.It became dislodged inside the patient and he was not able to retrieve.The procedure was completed with another capio¿ slim.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 stable.

• 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: 6497269
• MDR Text Key: 72920690
• Report Number: 3005099803-2017-01080
• Device Sequence Number: 1
• Product Code: FHQ
• UDI-Device Identifier: 08714729842224
• UDI-Public: (01)08714729842224(17)20190627(10)0019418628
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2017

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 Expiration Date: 06/27/2019
• Device Model Number: M0068318261
• Device Catalogue Number: 831-826
• Device Lot Number: 0019418628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2017
• Initial Date FDA Received: 04/17/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2016
• 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