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

Model Number	M0066201010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records of the specimen 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.
Event or Problem Description
Per cnf, it was reported that: when the 0.038 guidewire enclosed with the 8fr urinary diversion stent prepared for sj stent replacement was inserted into the 7fr sj stent that had already been implanted inside the patient, resistance was felt and the stent could not be removed.Tried to removed it as it was, the guide wire was torn.The remaining guidewire in the sj stent that was subsequently shredded and left in the sj stent could be removed, so it was changed to a terumo radifocus guidewire and the procedure of ureteral stenosis dilatation and 8 fr sj stent placement was completed.
Additional Manufacturer Narrative
Device analysis completed and codes added.
Event or Problem Description
Per cnf, it was reported that: when the 0.038 guidewire enclosed with the 8fr urinary diversion stent prepared for sj stent replacement was inserted into the 7fr sj stent that had already been implanted inside the patient, resistance was felt and the stent could not be removed.Tried to removed it it as it was, the guide wire was torn.The remaining guidewire in the sj stent that was subsequently shredded and left in the sj stent could be removed, so it was changed to a terumo radifocus guidewire and the procedure of ureteral stenosis dilatation and 8 fr sj stent placement was completed.

• 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: 11045779
• Report Number: 9681477-2020-00023
• Device Sequence Number: 16415824
• Product Code: DQX
• UDI-Device Identifier: 08714729005711
• UDI-Public: (01)08714729005711(17)240630(10)5780469
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K935170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2021

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: 06/30/2024
• Device Model Number: M0066201010
• Device Catalogue Number: 620-101
• Device Lot Number: 5780469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 01/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1