MAUDE Adverse Event Report: LAKE REGION MEDICAL LIMITED PHOENIX GUIDEWIRE

Model Number	OFG2524LF
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Nature of complaint: the intervention was in the lower limb, the artery was very hard calcified.The lesion was passed with a regular guide wire, afterwards with der the phoenix guidewire, as there was no chance to cross the lesion with a pta balloon (2.0).The phoenix - guidewire was shredded by the phoenix 1.5 while putting much effort into the heavy calcified lesion.The shredded guidewire sent was from the complaint issue.The shredded guidewire and the phoenix 1.5 were not removable separately, so they were removed together.With much effort the separated guidewire was removed from the distal part of phoenix 1.5 (outside of the body).As phoenix 1.5 sound well after removement, it was used again.With a 2nd gw (different box) the target lesion was treated successfully, as it was luckily possible to pass the lesion again.There were no radiopaque wire parts visible.Facility name: (b)(6).Additional information received 11/18/2021: was there any physical damage observed on the device? yes.If the device was damaged: please describe: shredded.Did any portion of the device separate within the patient? yes.Was there any patient injury? no.Was there any additional intervention performed? yes.Additional information received 11/22/2021: the phoenix - guidewire was shredded by the phoenix 1.5 while putting much effort into the heavy calcified lesion.With much effort the separated guidewire was removed from the distal part of phoenix 1.5 (outside of the body).As phoenix 1.5 found well after re-movement, it was used again.There were no radiopaque wire parts visible.
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 (b)(6) medical and was determined to be acceptable.
Additional Manufacturer Narrative
Device evaluation completed.
Event or Problem Description
Nature of complaint: the intervention was in the lower limb, the artery was very hard calcified.The lesion was passed with a regular guide wire, afterwards with der the phoenix guidewire, as there was no chance to cross the lesion with a pta balloon (2.0).The phoenix - guidewire was shredded by the phoenix 1.5 while putting much effort into the heavy calcified lesion.The shredded guidewire sent was from the complaint issue.The shredded guidewire and the phoenix 1.5 were not removable separately, so they were removed together.With much effort the separated guidewire was removed from the distal part of phoenix 1.5 (outside of the body).As phoenix 1.5 sound well after removement, it was used again.With a 2nd gw (different box) the target lesion was treated successfully, as it was luckily possible to pass the lesion again.There were no radiopaque wire parts visible.Facility name: kantonsspital baden additional information received 11/18/2021: 2.Was there any physical damage observed on the device? yes a.If the device was damaged: b.Please describe: shredded 3.Did any portion of the device separate within the patient? yes 4.Was there any patient injury? no 5.Was there any additional intervention performed? yes additional information received 11/22/2021: the phoenix - guidewire was shredded by the phoenix 1.5 while putting much effort into the heavy calcified lesion.With much effort the separated guidewire was removed from the distal part of phoenix 1.5 (outside of the body).As phoenix 1.5 found well after re-movement, it was used again.There were no radiopaque wire parts visible.
Additional Manufacturer Narrative
Error noted in g3 of follow up 1 report - date should read (b)(6) 2022.Amended report to product problem (b1) as additional information received 3 february 2022.Also amended b5 to include additional information received.H6 amended to 2199 in line with update that no intervention was required.
Event or Problem Description
Nature of complaint: the intervention was in the lower limb, the artery was very hard calcified.The lesion was passed with a regular guide wire, afterwards with der the phoenix guidewire, as there was no chance to cross the lesion with a pta balloon (2.0).The phoenix - guidewire was shredded by the phoenix 1.5 while putting much effort into the heavy calcified lesion.The shredded guidewire sent was from the complaint issue.The shredded guidewire and the phoenix 1.5 were not removable separately, so they were removed together.With much effort the separated guidewire was removed from the distal part of phoenix 1.5 (outside of the body).As phoenix 1.5 sound well after removement, it was used again.With a 2nd gw (different box) the target lesion was treated successfully, as it was luckily possible to pass the lesion again.There were no radiopaque wire parts visible.Facility name: (b)(6).Additional information received (b)(6) 2021: was there any physical damage observed on the device? yes.If the device was damaged: please describe: shredded.Did any portion of the device separate within the patient? yes.Was there any patient injury? no.Was there any additional intervention performed? yes.Additional information received (b)(6) 2021: the phoenix - guidewire was shredded by the phoenix 1.5 while putting much effort into the heavy calcified lesion.With much effort the separated guidewire was removed from the distal part of phoenix 1.5 (outside of the body).As phoenix 1.5 found well after re-movement, it was used again.There were no radiopaque wire parts visible.Additional information received (b)(6) 2022 confirming no required intervention to prevent injury: with the failure of the wire the used phoenix was not affected, therefore they have removed everything out of the patient, then removed the wire from the phoenix atherectomy device outside of the patient and used another phoenix guidewire to pass the lesion and treat the patient with the new guidewire and the phoenix catheter.No material remained in the patient and the patient could be treated without any further problems after that.

• 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
• Manufacturer (Section G): LAKE REGION MEDICAL LIMITED; butlersland; new ross; co. wexford, Y34 K 825; EI Y34 K825
• Manufacturer Contact: suzanne foley ; butlersland; new ross; co. wexford, Y34 K-825 ; EI Y34 K825
• MDR Report Key: 12891340
• Report Number: 9681477-2021-00020
• Device Sequence Number: 4571459
• Product Code: DQX
• UDI-Device Identifier: 10845225002760
• UDI-Public: (01)10845225002760(17)240711(10)6427029
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 02/04/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/11/2024
• Device Model Number: OFG2524LF
• Device Catalogue Number: PG14300LF
• Device Lot Number: 6427029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 05/01/2022; 02/03/2022
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 01/14/2022; 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 64 KG
• Patient Race: White