MAUDE Adverse Event Report: LAKE REGION MEDICAL LIMITED PHOENIX GUIDEWIRE

Model Number	OFG2524LF
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	02/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product not yet received for analysis.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.
Event or Problem Description
Phoenix was prepared in a normal way.Handle was connected and flushed, torquer was used during the atherectomy.The treatment was an atherectomy with the phoenix device of two lesions in the right sfa and poplitea.During the second passage of the distal lesion the handle stopped twice.The physician reconnected the handle and we could proceed the 2nd passage of the distal popliteal lesion.The control angiography showed than a dissection in the popliteal segment and a leak of contrast media.The physician decided to make a prolonged dilatation ( boston scientific balloon 5x100) over 10 minutes with an outside pressure with a blood pressure cuff.First control showed a good result with no leaks of contrast media anymore.He treated the proximal lesion as well with an angioplasty balloon 5/100.After all he checked the whole leg from proximal up to the foot.In consultation with the vascular surgeon the decision was to keep it without stenting.Patient was fine all the time, no pain, no issues.
Event or Problem Description
Phoenix was prepared in a normal way.Handle was connected and flushed, torquer was used during the atherectomy.The treatment wasan atherectomy with the phoenix device of two lessions in the right sfa and poplitea.Dzuring the second passage of the distal lession the handle stopped twice.The physician reconnected the handle and we could proceed the 2nd passage of the distal popliteal lession.The control angiography showed than a dissection in the popliteal segment and a leak of contrast media.The physician decided to make a prolonged dilatation ( boston scientific balloon 5x100) over 10 minutes with an outside pressure with a blood pressure cuff.First control showed a good result with no leaks of contrast media anymore.He treated the proximal lession as well with an angioplasty balloon 5/100.After all he checked the whole leg from proximal up to the foot.In consultation with the vascular surgeon the decision was to keep it without stenting.Patient was fine all the time, no pain, no issues.
Additional Manufacturer Narrative
Unique identifier (udi) # corrected as the incorrect number was entered on the initial and fu1 reports in error.
Event or Problem Description
Phoenix was prepared in a normal way.Handle was connected and flushed, torquer was used during the atherectomy.The treatment wasan atherectomy with the phoenix device of two lessions in the right sfa and poplitea.Dzuring the second passage of the distal lession the handle stopped twice.The physician reconnected the handle and we could proceed the 2nd passage of the distal popliteal lession.The control angiography showed than a dissection in the popliteal segment and a leak of contrast media.The physician decided to make a prolonged dilatation ( boston scientific balloon 5x100) over 10 minutes with an outside pressure with a blood pressure cuff.First control showed a good result with no leaks of contrast media anymore.He treated the proximal lession as well with an angioplasty balloon 5/100.After all he checked the whole leg from proximal up to the foot.In consultation with the vascular surgeon the decision was to keep it without stenting.Patient was fine all the time, no pain, no issues.

• 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: 11741822
• Report Number: 9681477-2021-00007
• Device Sequence Number: 17062145
• Product Code: DQX
• UDI-Device Identifier: 10845225002746
• UDI-Public: (01)10845225002746(17)210701(10)11012470
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2021
• Device Model Number: OFG2524LF
• Device Catalogue Number: PG14300LF
• Device Lot Number: 11018187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 05/10/2021; 07/26/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 05/31/2021; 07/27/2021
• 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: PHOENIX CATHETER, 2,4MM X 127 CM, 7F DFM; PHOENIX CATHETER, 2,4MM X 127 CM, 7F DFM; PHOENIX CATHETER, 2,4MM X 127 CM, 7F DFM
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR