MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPIO SLIM; HOLDER, NEEDLE, GASTROENTEROLOGIC

Model Number M0068318261

Device Problems Retraction Problem (1536); Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/17/2024

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a capio slim device was used during a vaginal prolpase repair procedure in the vagina, performed on (b)(6) 2024.During the procedure, the device would not hold the suture.Another capio slim was opened and used to successfully complete the procedure.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation results; sling carrier removal failed.Please see block h10 for full investigation details.

Manufacturer Narrative

Block h6: imdrf device code a0501 captures the reportable investigation result of carrier retraction problem.Block h10: upon receipt at our quality assurance laboratory, this capio device underwent a thorough analysis.A functional analysis was performed and there was no problem in loading the suture into the carrier.However, the device returned with the carrier partially exposed, and the device did not retract properly.Also, the carrier was misaligned.A review of the device history record (dhr) indicated that the device met all material, assembly, and product specifications at the time of release to distribution.Based on the information available and analysis results, the reported allegation of device failure to load/engage suture was not confirmed, since after visual, microscope and functional inspections in the complaint device, it was not possible to identify any evidence of the alleged issue.However, even the device passes the functional inspection, it was returned with the carrier not fully retracted; further investigation is in progress to address this observation.A conclusion code of cause not established was assigned to this investigation.

• Brand Name: CAPIO SLIM
• Type of Device: HOLDER, NEEDLE, GASTROENTEROLOGIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18961816
• MDR Text Key: 338386467
• Report Number: 2124215-2024-16398
• Device Sequence Number: 1
• Product Code: FHQ
• UDI-Device Identifier: 08714729842224
• UDI-Public: 08714729842224
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0068318261
• Device Catalogue Number: 831-826
• Device Lot Number: 0032420869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2023
• 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 Age: 66 YR
• Patient Sex: Female