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 No Consequences Or Impact To Patient (2199)

Event Date 02/19/2018

Event Type  malfunction  

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 a sacrospinous fixation procedure performed on (b)(6) 2018.According to the complainant, after the procedure, the nurse found out that the dart was missing on one of the sutures during the dart count.It was thought to be left inside the patient.The patient was then x-rayed but nothing was found.Reportedly, the dart was found after the capio cage was inspected.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

A visual examination of the returned capio slim revealed that the head halves come apart and due to this condition the functional test could not be performed.In addition, there is evidence that the riveting process was done correctly.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 failure found (head halves apart) could have been caused by excessive manipulation of the device by the user or an excess of torsional force applied on the tip of the device during procedure.Additionally, the device has evidence that the riveting process was done correctly.Therefore, the most probable cause of this complaint is operational context since due to anatomical and/or procedural factors encountered during the procedure, the device performance was limited.

Event Description

It was reported to boston scientific corporation that a capio slim was used during a sacrospinous fixation procedure performed on (b)(6) 2018.According to the complainant, after the procedure, the nurse found out that the dart was missing on one of the sutures during the dart count.It was thought to be left inside the patient.The patient was then x-rayed but nothing was found.Reportedly, the dart was found after the capio cage was inspected.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: 7330911
• MDR Text Key: 102113463
• Report Number: 3005099803-2018-00646
• Device Sequence Number: 1
• Product Code: FHQ
• UDI-Device Identifier: 08714729842224
• UDI-Public: 08714729842224
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2020
• Device Model Number: M0068318261
• Device Catalogue Number: 831-826
• Device Lot Number: 0020196783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2018
• Initial Date FDA Received: 03/12/2018
• Supplement Dates Manufacturer Received: 04/09/2018
• Supplement Dates FDA Received: 04/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2017
• 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