MAUDE Adverse Event Report: BIOSPHERE MEDICAL SA TENOR MICRO GUIDE WIRE; VASCULAR GUIDEWIRE

Model Number	00884450093641
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up report will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during a transarterial chemoembolization (tace) procedure, approximately 5 cm of the guidewire detached within the patient's peripheral blood vessel.The physician decided not to retrieve the detached portion of the device as the patient was noted to be not unwell.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: TENOR MICRO GUIDE WIRE
• Common Device Name: VASCULAR GUIDEWIRE
• Manufacturer (Section D): BIOSPHERE MEDICAL SA; parc des nations, paris nord 2; 383, rue de la belle etoile; 95700 ; FR 95700
• MDR Report Key: 9594323
• Report Number: 9615728-2020-00001
• Device Sequence Number: 2353349
• Product Code: DQX
• UDI-Device Identifier: 00884450093641
• UDI-Public: 00884450093641
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K061171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2019

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 Expiration Date: 10/31/2021
• Device Model Number: 00884450093641
• Device Catalogue Number: TNR2411/CN
• Device Lot Number: 4540293
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1