MAUDE Adverse Event Report: LAKE REGION MEDICAL LIMITED PHOENIX GUIDEWIRE

Model Number	PG14300LF
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was provided for analysis.As reported by the customer: 'when changing the wire from a 14 volcano to an 18 wire overlying balloon catheter, medtronic in.Pact pacific paclitaxel eluting size 5/120/130, tear off the flexible non-coated tip of the 014 wire with subsequent outflow into 2 dital lower leg arteries with one (ata) being laid distally.'' there was also additional information provided, which noted that 'the tip of the wire was cut of by the phoenix cutterhead.The tip floated distal and blocked the vessel a.Fibularis completely.Patient was on intensive care afterwards.'' it was also stated that 'after being on intensice care for some hours, patient could go home.But the wire tip is still in his arteries somewhere''.Based on the evidence presented by the picture and additional information it is "unknown/unclear due to insufficient information" what may have impacted on the event as reported.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.At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the evidence presented by the sample and the information provided by the supporting documentation, "device forced against resistance", "excessive force used", "device used at sub optimal indications", "excessive force", "inexperienced user", "unanticipated user error" and/or "improper handling" appear to have impacted on the event as reported.
Event or Problem Description
When changing the wire from a 14 volcano to an 18 wire overlying balloon catheter, medtronic in.Pact pacific paclitaxel eluting size 5/120/130, tear off the flexible non-coated tip of the 014 wire with subsequent outflow into 2 dital lower leg arteries with one (ata) being laid distally.Further information is also available from (b)(6).Dr.(b)(6).

• Brand Name: PHOENIX 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: 10775414
• Report Number: 9681477-2020-00015
• Device Sequence Number: 19117313
• Product Code: DQX
• UDI-Device Identifier: 10845225002760
• UDI-Public: (01)10845225002760(17)210909(10)11060276
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K080144
• 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
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 10/15/2020

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: 09/09/2021
• Device Model Number: PG14300LF
• Device Lot Number: 11060276
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 11/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1