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

Model Number M0068318261

Device Problems Mechanical Problem (1384); Retraction Problem (1536)

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

Event Date 12/13/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a0501 captures the reportable investigation finding of sling carrier removal failed.Block h10: the returned capio slim device was analyzed and a visual inspection of the device revealed that the carrier was partially exposed and also the carrier was bent/kinked.With all available information, boston scientific corporation concludes that the reported allegations of carrier failure to extend could not be confirmed since after visual, microscopic and functional inspections in the complaint device, it was not possible to identify any evidence of the alleged issue.Additionally, even the device has passed the functional inspection, it was returned with the carrier not fully retracted and the sling carrier was bent/kinked.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 carrier failure to extend was not confirmed.Furthermore, it was confirmed through analysis that the device carrier was not fully retracted; the investigation concluded that the most probable cause for this complaint is cause not established.An investigation to address this problem is in progress.

Event Description

It was reported to boston scientific corporation that a capio slim device was used during a sacrospinous fixation (ssf) procedure performed on (b)(6) 2023.During the procedure, the device failed to extend when it was actuated.Another capio slim was opened and used to successfully complete the procedure.There were no patient complications as a result of the 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.

• 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: 18813485
• MDR Text Key: 337572922
• Report Number: 2124215-2024-10734
• Device Sequence Number: 1
• Product Code: FHQ
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• 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: 0031876830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2024
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2023
• 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