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

Model Number M0068311251

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/18/2017

Event Type  Injury  

Manufacturer Narrative

Problem of needle detachment.The complainant indicated that the device is disposed and will not 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.(b)(4).

Event Description

It was reported to boston scientific corporation that an uphold¿ lite was used during a total vaginal hysterectomy, anterior and posterior colporrhaphy, sacrospinous ligament fixation, and diagnostic cystoscopy procedure performed on (b)(6) 2017.According to the complainant, during the procedure, after the capio device was deployed, the suture needle detached and was missing.The needle was never found and may have been left inside the patient.The procedure was completed with this device with another capio suture.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¿
• 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: 6410543
• MDR Text Key: 70117669
• Report Number: 3005099803-2017-00657
• Device Sequence Number: 1
• Product Code: FHQ
• UDI-Device Identifier: 08714729257615
• UDI-Public: (01)08714729257615(17)20190120(10)18831921
• 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: 02/22/2017

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: 01/20/2019
• Device Model Number: M0068311251
• Device Catalogue Number: 831-125
• Device Lot Number: 18831921
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2017
• Initial Date FDA Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2016
• 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: 62 YR