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 11/01/2017

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 mdr will be filed.

Event Description

It was reported to boston scientific corporation that a capio¿ slim device was used during a sacrospinous ligament fixation procedure performed on (b)(6) 2017.According to the complainant, during procedure, the needle detached from the suture.An x-ray was taken and it showed the needle inside the patient.The physician decided not to retrieve the needle from the patient to prevent ligament tear as it was covered with ligaments.The procedure was completed with another capio¿ slim 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.

Manufacturer Narrative

Two devices were returned.However, analysis found that none of them have any visible failures, and their carriers were 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.After analysis it was determined that the devices did not present any visual issues and it worked as intended.Returned devices review includes visual and functional evaluations, which showed no evidence of either the alleged issue or any defect that could have contributed to the event reported.Therefore the most probable cause for the complaint is not confirmed-returned.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 device was used during a sacrospinous ligament fixation procedure performed on (b)(6) 2017.According to the complainant, during procedure, the needle detached from the suture.An x-ray was taken and it showed the needle inside the patient.The physician decided not to retrieve the needle from the patient to prevent ligament tear as it was covered with ligaments.The procedure was completed with another capio slim 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¿ 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: 7064751
• MDR Text Key: 93130055
• Report Number: 3005099803-2017-03486
• Device Sequence Number: 1
• Product Code: FHQ
• UDI-Device Identifier: 08714729842224
• UDI-Public: 08714729842224
• 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: 11/02/2017

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: 07/19/2020
• Device Model Number: M0068318261
• Device Catalogue Number: 831-826
• Device Lot Number: 20908772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2017
• Initial Date FDA Received: 11/28/2017
• Supplement Dates Manufacturer Received: 12/12/2017
• Supplement Dates FDA Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2017
• 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
• Patient Outcome(s): Other