MAUDE Adverse Event Report: LAKE REGION MEDICAL LIMITED BENTSON TYPE PTFE COATED GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number	M0066201010
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The observation made during investigation showed that the returned pouch had been damaged.A number of scratches and a hole were present in one area on the back of the pouch.However, it is very unlikely that this damage would have went unnoticed during the 100% inspection completed in packaging.A review of the device history records of 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.Based on the evidence presented by the sample and the information provided by the supporting documentation "package integrity compromised" and/or "inadequate shipping support" might have impacted on the event as reported.
Event or Problem Description
The customer initially reported that "the bag was torn, and the product bag inside got damaged/scratched".The observation made during our investigation showed that the returned pouch had been damaged.

• Brand Name: BENTSON TYPE PTFE COATED GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): LAKE REGION MEDICAL LIMITED; butlersland; new ross; co. wexford, Y34K8 25; EI Y34K825
• MDR Report Key: 9098135
• Report Number: 9681477-2019-00013
• Device Sequence Number: 2700709
• Product Code: DQX
• UDI-Device Identifier: 08714729005711
• UDI-Public: 08714729005711
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K935170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2019

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: Other
• Device Expiration Date: 06/30/2023
• Device Model Number: M0066201010
• Device Lot Number: 4828379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1