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

Model Number M0068318261

Device Problems Retraction Problem (1536); Use of Device Problem (1670); Device-Device Incompatibility (2919)

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

Event Date 10/20/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a0510 captures the reportable event of carrier stuck in the cage.

Event Description

It was reported to boston scientific corporation that a capio slim was used during a sacrospinous fixation procedure on october 20, 2023.During the procedure, it was difficult to load the suture on all three devices used.It has been confirmed that the capio carrier extended, but the suture needle was not caught in the catch/cage.There were also issues upon loading the suture into the capio device.Additionally, the carriers got stuck in the cage.The procedure was completed with another capio slim.There were no patient complications as a result of the event.

Event Description

It was reported to boston scientific corporation that a capio slim was used during a sacrospinous fixation procedure on (b)(6) 2023.During the procedure, it was difficult to load the suture on all three devices used.It has been confirmed that the capio carrier extended, but the suture needle was not caught in the catch/cage.There were also issues upon loading the suture into the capio device.Additionally, the carriers got stuck in the cage.The procedure was completed with another capio slim.There were no patient complications as a result of the event.

Manufacturer Narrative

Block h6: imdrf device code a0510 captures the reportable event of carrier stuck in the cage.Block h10: with all the available information, boston scientific concludes that the reported event of cage failed to catch, device failure to load engage/suture, and carrier unable to retract were defined in the risk documentation.During the functional inspection, the carrier was able to move in and out.After deploying the carrier, the cage was able to catch the suture, in the same way the suture could be loaded without any complication, and the retraction of the device was also carried out without problem.Therefore, the reported complaint is not confirmed.After the product analysis, it was determined that the device did not have any visual issue/damage.During the functional inspection, the carrier was able to move in and out.After deploying the carrier, the cage was able to catch the suture, in the same way the suture could be loaded without any complication, and the retraction of the device was also carried out without problem.Additionally, the unit returned did not show evidence of either the alleged issue(s) or any defect which could have contributed to the event.Based on this, the investigation concluded that the most probable cause for this is "no problem detected" since the device complaint or problem cannot be confirmed.

• 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: 18151650
• MDR Text Key: 328512303
• Report Number: 2124215-2023-62829
• Device Sequence Number: 1
• Product Code: FHQ
• UDI-Device Identifier: 08714729842224
• UDI-Public: 08714729842224
• 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,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• 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: 0031809880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2023
• 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