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

Device Problems Retraction Problem (1536); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/09/2024

Event Type  malfunction  

Event Description

A capio device was returned to boston scientific corporation.This product was returned to the manufacturer without any report of performance issues or adverse patient effects.The returned capio device was analyzed, and this event has been deemed reportable based on the investigation results.Boston scientific has been unable to obtain additional information regarding the circumstances surrounding this event despite good faith efforts.Please see block h10 for full investigation details.

Manufacturer Narrative

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 investigation result of carrier retraction problem.Block h10: upon receipt at our quality assurance laboratory, this capio device underwent a thorough analysis.Visual inspection of the device did not reveal any anomalies.Functional testing performed noted the carrier was able to move out, but the carrier did not retract completely.When the carrier was deployed, the cage was able to catch the suture.With all available information, the analysis of the returned device confirmed that the capio presented a retraction anomaly as the carrier could not fully retract into the head of the device.Based on the information available, a conclusion code of cause not established was assigned to this investigation.

• 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: 18763559
• MDR Text Key: 336976214
• Report Number: 2124215-2024-10212
• Device Sequence Number: 1
• Product Code: FHQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2024
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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