MAUDE Adverse Event Report: LAKE REGION MEDICAL LIMITED PHOENIX GUIDEWIRE

Model Number	OFG2524LF
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Complaint #: (b)(4).Date of event: (b)(6) 2023.Reportability aware date: (b)(6) 2023.Country: united states (usa).Nature of complaint: tip of the wire broke off in patient's foot.They were not able to remove the wire.The wire was in the collateral at a 90 degree angle.The wire is not scheduled to be removed from the patient's foot.The procedure was completed as scheduled.Facility name: (b)(6).Facility contact name: (b)(6).Facility contact #: (b)(6).Facility contact email: (b)(6).Address: (b)(6).Physician name: dr.(b)(6).Was physical damage to the device observed?* yes did any portion of the device become separated or detach within the patient?* yes did an embolization occur?: no procedure type: therapeutic peripheral vessel: at peripheral vessel segment: distal access approach: contralateral was the support clip used? (phoenix catheter) yes.Was the device flushed per the ifu? yes.Product being returned?* yes.
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.At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided by the supporting documentation, "inexperienced user", "operational context", "improper handling", "excessive force used", 'device forced against resistance", "unanticipated user error", "device used at sub optimal indications", "device forced against resistance" and/or "material fatigue" appears to have impacted on the event as reported.
Additional Manufacturer Narrative
The sample was returned in a zip-lock type bag labelled as a biohazard and placed in a carton box.The main body of the guidewire was coiled into a circular shape a visual inspection of the returned guidewire confirmed that the guidewire was fractured.The distal end of the guidewire was stretched and unravelled.A microscopic examination of the guidewire distal end revealed that the distal weld was not present and was not located in any of the returned packaging.A microscopic examination of the guidewire proximal joint revealed that the proximal joint was intact however, the coil was stretched leading up to the joint.No other damage was noted on the returned product.A dimensional examination of the returned guidewire was completed, and the following features were observed: guidewire part number vol#003-01g is the guidewire used per volbf-001 packaging drawing tab table.Per vol#003-01g drawing, the guidewire should be 300 cm ± 2 cm in overall length.The returned guidewire measured approximately 298.5 cm in overall length.This guidewire is a 2- piece construction: coil and core.Core length from the proximal joint to the fracture point measured approximately 4.5 cm.According to the guidewire drawing vol#003-01g the length of the mandrel from proximal joint to the distal tip should be 5.5 cm, which reflected approximately 1 cm of distal section being removed.The core diameter at fracture point measured 0.00375''.The specification of straight core section is 0.0035 +/-.0004'' as per vol#003r drawing, which confirmed that fracture occurred on the core straight section approximately 1 cm from the distal tip.The observation made during the analysis found that the returned guidewire was fractured.A microscopic examination of the guidewire proximal joint revealed that the proximal joint was intact, however, the coil was unravelled and stretched leading up to the joint.A microscopic examination of the guidewire distal end revealed that the distal weld was not present and was not located in any of the returned packaging.A dimensional examination was completed and determined that fracture occurred on the core straight section approximately 1 cm from the distal tip.The fracture surface was evaluated in salem met lab by sem, and the following conclusions were reported: 1.The sem analysis indicated that the wire fractured due to torsional overload.2.There was no evidence of pre-existing detrimental features.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.At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided by the supporting documentation, "inexperienced user", "operational context", "improper handling", "excessive force used", [?]'device forced against resistance", "unanticipated user error", "device used at sub optimal indications", "device forced against resistance" and/or "material fatigue" appears to have impacted on the event as reported.
Event or Problem Description
Complaint # (b)(4).Date of event: (b)(6).Reportability aware date: (b)(6) 2023.Country: united states (usa).Nature of complaint: tip of the wire broke off in patient's foot.They were not able to remove the wire.The wire was in the collateral at a 90 degree angle.The wire is not scheduled to be removed from the patient's foot.The procedure was completed as scheduled.Facility name: (b)(6).Facility contact name:(b)(6).Facility contact #: (b)(6).Facility contact email:(b)(6).Address: (b)(6).Physician name: (b)(6).Was physical damage to the device observed?* (b)(6).Did any portion of the device become separated or detach within the patient?* yes.Did an embolization occur?: no.Procedure type: therapeutic.Peripheral vessel: at peripheral vessel segment: distal.Access approach: contralateral.Was the support clip used? (phoenix catheter) yes.Was the device flushed per the ifu? yes.Product being returned?* yes.
Additional Manufacturer Narrative
The sample was returned in a zip-lock type bag labelled as a biohazard and placed in a carton box.The main body of the guidewire was coiled into a circular shape · a visual inspection of the returned guidewire confirmed that the guidewire was fractured.· the distal end of the guidewire was stretched and unravelled.· a microscopic examination of the guidewire distal end revealed that the distal weld was not present and was not located in any of the returned packaging.· a microscopic examination of the guidewire proximal joint revealed that the proximal joint was intact however, the coil was stretched leading up to the joint.· no other damage was noted on the returned product.A dimensional examination of the returned guidewire was completed, and the following features were observed: · guidewire part number vol#003-01g is the guidewire used per volbf-001 packaging drawing tab table.Per vol#003-01g drawing, the guidewire should be 300 cm ± 2 cm in overall length.The returned guidewire measured approximately 298.5 cm in overall length.· this guidewire is a 2- piece construction: coil and core.Core length from the proximal joint to the fracture point measured approximately 4.5 cm.According to the guidewire drawing vol#003-01g the length of the mandrel from proximal joint to the distal tip should be 5.5 cm, which reflected approximately 1 cm of distal section being removed.· the core diameter at fracture point measured 0.00375''.The specification of straight core section is 0.0035 +/-.0004'' as per vol#003r drawing, which confirmed that fracture occurred on the core straight section approximately 1 cm from the distal tip.The observation made during the analysis found that the returned guidewire was fractured.A microscopic examination of the guidewire proximal joint revealed that the proximal joint was intact, however, the coil was unravelled and stretched leading up to the joint.A microscopic examination of the guidewire distal end revealed that the distal weld was not present and was not located in any of the returned packaging.A dimensional examination was completed and determined that fracture occurred on the core straight section approximately 1 cm from the distal tip.The fracture surface was evaluated in salem met lab by sem, and the following conclusions were reported: 1.The sem analysis indicated that the wire fractured due to torsional overload.2.There was no evidence of pre-existing detrimental features.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.At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided by the supporting documentation, "inexperienced user", "operational context", "improper handling", "excessive force used", [?]'device forced against resistance", "unanticipated user error", "device used at sub optimal indications", "device forced against resistance" and/or "material fatigue" appears to have impacted on the event as reported.
Event or Problem Description
Complaint # (b)(4).Date of event: 4/21/2023.Reportability aware date: 4/21/2023.Country: united states (usa).Nature of complaint: tip of the wire broke off in patient's foot.They were not able to remove the wire.The wire was in the collateral at a 90 degree angle.The wire is not scheduled to be removed from the patient's foot.The procedure was completed as scheduled.Facility name: (b)(6).Facility contact name: (b)(6).Facility contact #: (b)(6).Facility contact email: (b)(6).Address: (b)(6).United states physician name: dr.(b)(6).Was physical damage to the device observed?* yes.Did any portion of the device become separated or detach within the patient?* yes.Did an embolization occur?: no.Procedure type: therapeutic.Peripheral vessel: at peripheral vessel segment: distal.Access approach: contralateral.Was the support clip used? (phoenix catheter) yes.Was the device flushed per the ifu? yes.Product being returned?* yes.

• Brand Name: PHOENIX GUIDEWIRE
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): LAKE REGION MEDICAL LIMITED; butlersland; new ross; co. wexford, ireland Y34 K 825; EI Y34 K825
• Manufacturer (Section G): LAKE REGION MEDICAL LIMITED; butlersland; new ross; co. wexford, ireland Y34 K 825; EI Y34 K825
• Manufacturer Contact: glenn phelan ; EI
• MDR Report Key: 16895085
• Report Number: 9681477-2023-00002
• Device Sequence Number: 12284840
• Product Code: DQX
• UDI-Device Identifier: 10845225002760
• UDI-Public: (01)10845225002760(17)251027(10)6996979
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/07/2023

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: 10/27/2025
• Device Model Number: OFG2524LF
• Device Lot Number: 6996979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2023
• Supplement Date Received by Manufacturer: 05/19/2023; 05/19/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 06/07/2023; 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American