MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) CAPIO¿; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number M0068311251

Device Problems Detachment Of Device Component (1104); Retraction Problem (1536)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/12/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Analysis of the returned device revealed that the device does not have any 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.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.Based on all gathered information and investigation results, there is no evidence of either the alleged issue or any defect which could have contributed to the event.Therefore, the reported issue was unable to be confirmed.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¿ device was used during a sacrospinous ligament fixation procedure performed on (b)(6).According to the complainant, during procedure, upon deployment of the mesh arm in the sacrospinous ligament, the needle detached and the carrier failed to retract.The physician had to leave the needle in the patient.The procedure was completed with another capio¿ device.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¿
• 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: 6998739
• MDR Text Key: 90940818
• Report Number: 3005099803-2017-03222
• Device Sequence Number: 1
• Product Code: FHQ
• UDI-Device Identifier: 08714729257615
• UDI-Public: 08714729257615
• 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
• Report Date: 10/12/2017

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: 10/18/2019
• Device Model Number: M0068311251
• Device Catalogue Number: 831-125
• Device Lot Number: 0019856248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2017
• Initial Date FDA Received: 11/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2016
• 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
• Patient Age: 77 YR