MAUDE Adverse Event Report: BIOSPHERE MEDICAL, S.A. TORPEDO; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Catalog Number	TOR2520
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event was identified during internal quality system activities.Upon review, the manufacturer determined the event meets fda criteria for reporting.The report is being submitted to ensure accuracy and completeness of mdr files.This submission does not reflect a change in device performance or patient risk.The awareness date corresponds to when the manufacturer became aware of the event details.All information reasonably known to the manufacturer at this time has been included.The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.Nonconformances of this nature are monitored by the operation team.
Event or Problem Description
The customer reports the gel will not deploy, it gets stuck in the torpedo or stuck to the pusher.No additional information was provided.

• Brand Name: TORPEDO
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BIOSPHERE MEDICAL, S.A.; parc des nations paris nord 2; 383 rue de la belle etoile; roissy-en-france 95700 ; FR 95700
• Manufacturer (Section G): BIOSPHERE MEDICAL SA; parc des nations-paris nord 2; 383 rue de la belle etole; roissy-en-france 95700 ; FR 95700
• Manufacturer Contact: marie-laure patucca ; parc des nations paris nord 2; 383 rue de la belle etoile; roissy-en-france 95700 ; FR 95700
• MDR Report Key: 24872967
• Report Number: 9615728-2026-00069
• Device Sequence Number: 13011565
• Product Code: KRD
• UDI-Device Identifier: 00884450408834
• UDI-Public: 00884450408834
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K192480
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: TOR2520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown