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

Model Number M0068318250

Device Problem Retraction Problem (1536)

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

Event Date 01/18/2024

Event Type  malfunction  

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a0501 captures the reportable event of carrier retraction problem.

Event Description

It was reported to boston scientific corporation that a capio slim device was used during a prolapse repair surgery procedure in the bladder, performed on (b)(6) 2024.During the procedure, there was resistance when the physician attempted to deploy the needle.The capio device was cleaned and successfully completed the procedure.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a0501 captures the reportable event of carrier retraction problem.Block h11: block b5 has been updated based on the additional information received on march 15, 2024.Block g1 mfr site city, and block h6 device code, have been corrected.Additional information was received from the complainant on march 15, 2024, clarifying that the carrier failed to extend.Although this can result in a clinically insignificant delay of the procedure, this event is unlikely to cause or contribute to a death or serious injury if the malfunction were to recur.Therefore, boston scientific no longer considers this to be a reportable event.

Event Description

It was reported to boston scientific corporation that a capio slim device was used during a prolapse repair surgery procedure in the bladder, performed on (b)(6) 2024.During the procedure, there was resistance when the physician attempted to deploy the needle.The capio device was cleaned and successfully completed the procedure.There were no patient complications reported as a result of this event.Additional information received on march 15, 2024, stating that the capio carrier failed to extend when the device was actuated, and no retraction problem was noted.

• 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; 2546 calle primera ; CS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18903416
• MDR Text Key: 337658501
• Report Number: 2124215-2024-13955
• Device Sequence Number: 1
• Product Code: FHQ
• UDI-Device Identifier: 08714729838005
• UDI-Public: 08714729838005
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0068318250
• Device Catalogue Number: 831-825
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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