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

Device Problem Retraction Problem (1536)

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

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

Block b3: date of event was approximated to february 01, 2024, based on the date the manufacturer became aware of the event.Block d4, h4: the complainant was unable to provide the suspect device upn and 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 procedure performed.During the procedure, when the plunger was released, the dart did not retract into the capio.There was no information on what had completed the procedure.There were no patient complications as a result of the event.No further information has been obtained despite good faith efforts.

• Brand Name: CAPIO
• 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; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18813470
• MDR Text Key: 337543860
• Report Number: 2124215-2024-11241
• Device Sequence Number: 1
• Product Code: FHQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2024
• 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