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 Known Impact Or Consequence To Patient (2692)

Event Date 04/20/2017

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.The voluntary user medwatch number ("uf/importer report #") is (b)(4).

Event Description

It was reported to boston scientific corporation that a capio slim was used during an exploratory laparotomy, vaginal apical suspension, anterior posterior repair procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the capio carrier detached inside the patient.This required a laparotomy to find and remove the detached piece, and resulted to performing an open procedure, increased length of procedure, and anesthesia time.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 that the carrier was broken and the broken section of the carrier was not returned.  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 review and analysis of all available information fails to indicate a root cause or probable root cause.Therefore, the root cause of this complaint is undeterminable.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.An investigation is underway to address the failure of "carrier broken".

Event Description

It was reported to boston scientific corporation that a capio slim was used during an exploratory laparotomy, vaginal apical suspension, anterior posterior repair procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the capio carrier detached inside the patient.This required a laparotomy to find and remove the detached piece, and resulted to performing an open procedure, increased length of procedure, and anesthesia time.The procedure was completed with another capio slim.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: 6601300
• MDR Text Key: 76289570
• Report Number: 3005099803-2017-01581
• Device Sequence Number: 1
• Product Code: FHQ
• 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: 05/09/2017

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: 09/16/2019
• Device Model Number: M0068318261
• Device Catalogue Number: 831-826
• Device Lot Number: 0019730190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2017
• Initial Date FDA Received: 05/31/2017
• Supplement Dates Manufacturer Received: 07/14/2017
• Supplement Dates FDA Received: 08/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2016
• 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): Required Intervention
• Patient Age: 42 YR