MAUDE Adverse Event Report: LAKE REGION MEDICAL LIMITED BENTSON TYPE PTFE COATED GUIDEWIRE

Model Number	M0066201000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records for the specimen device does not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.Awaiting confirmation of device availability.
Event or Problem Description
Per cnf, it was reported that: ptfe guidewire was gripping onto the wire during stent deployment.Doctor found it difficult to remove the guidewire from the stent as he was deploying the contour.The stent was gripping onto the guidewire and the guidewire unravelled a bit.I've lodged a separate complaint for the contour stent.He felt a lot of pressure when he tried to remove the guidewire.Doctor requested to open another new stent and guidewire.He managed to stent patient successfully.Procedure was completed successfully.Patient is stable and well.
Additional Manufacturer Narrative
Customer confirmed device is not available for return due to covid concerns.
Event or Problem Description
Per cnf, it was reported that: ptfe guidewire was gripping onto the wire during stent deployment.Doctor found it difficult to remove the guidewire from the stent as he was deploying the contour.The stent was gripping onto the guidewire and the guidewire unravelled a bit.I?ve lodged a separate complaint for the contour stent.He felt a lot of pressure when he tried to remove the guidewire.Doctor requested to open another new stent and guidewire.He managed to stent patient successfully.Procedure was completed successfully.Patient is stable and well.

• Brand Name: BENTSON TYPE PTFE COATED GUIDEWIRE
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): LAKE REGION MEDICAL LIMITED; butlersland; new ross; co. wexford, Y34 K 825; EI Y34 K825
• MDR Report Key: 12352377
• Report Number: 9681477-2021-00014
• Device Sequence Number: 4417992
• Product Code: DQX
• UDI-Device Identifier: 08714729011408
• UDI-Public: (01)08714729011408(17)250228(10)6234036
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K935198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2021

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: 02/28/2025
• Device Model Number: M0066201000
• Device Catalogue Number: 620-100
• Device Lot Number: 6234036
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/04/2021
• Supplement Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONTOUR STENT; CONTOUR STENT; CONTOUR STENT