MAUDE Adverse Event Report: LAKE REGION MEDICAL LIMITED PHOENIX GUIDEWIRE

Catalog Number OFG2524LF

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/20/2024

Event Type  malfunction  

Event Description

We have received a complaint on phoenix light support guidewire: (b)(6), lot 7931939 where the outer coating of the phoenix wire and the tip broke off inside the patient.Please let us know if you have any further questions.Thank you.Complaint # (b)(4).Date of event: 3/20/2024.Reportability aware date: 3/22/2024.Country: germany (deu).Nature of complaint: at the start of rotational atherectomy with the phoenix (b)(6)the catheter hooked in a short segment, but after that continued problem free to pass in several angulations or sectors.Removal of the phoenix, angiography, here the outer coating of the phoenix wire is visible intraluminally over a longer distance.The distal tip is located in a collateral of the atp.The proximal section of the proximal afs can be found sonographically.No flow relevance.Removal of the remaining wire was unsuccessful.Dcb pta, implantation of a stent.Patient was fine and discharged in good condition.Device will be returned.Type of case: peripheral.Access location: femoral.Vessel tortuosity: none.Procedure type: therapeutic.Was resistance encountered?: yes.Lesion calcification: slight.Type of "target" lesion: fibrous.Peripheral vessel: sfa.Vessel segment: mid.Access approach: retrograde.Chronic total occlusion (cto)? unknown.Was the support clip used? (phoenix catheter): yes.Patient age and/or dob: 64.Patient weight: 100 kg.Patient sex: male.Any additional intervention(s) implemented?: snare, stent.Did the physician/facility report this ae to a regulatory agency?: unknown.If the device separated, where?: target lesion.What became of the separated portion of the device?: jailed/tacked to vessel wall.Procedure location: cath lab.Medical history /co-morbidities?: not available from facility.Pre-op labs/testing: not available from facility.1.Please provide a picture -attached.2.Was the tip of the phoenix gw separated? -the hcp suggested no.3.Was the coating of the phoenix gw separated? -the hcp suggested yes.4.What segment of the phoenix gw was missing the coating? -200 mm from tip.5.How much of the separated portion left in the patient? -200 mm.6.Where was the separated portion left (location in the body)? -sfa/pop segment.7.What segments were stented? -sfa.8.Was the catheter got stuck onto the guidewire? -no.9.Was the catheter and the guidewire removed as a system? -were removed separately 10.Was there any physical damage observed with the catheter? -no physical damage 11.Please provide patient information per us fda regulations: a.Ethnicity: not provided.B.Race: not provided.12.Did the physician believe the device caused/contributed to the ae? -no.1.Was unusual force ever required when using the device? -no.2.Was there any damage noted to the product packaging upon inspection prior to use? -no.3.Was there any reported difficulty removing the product from the packaging? - no.4.Was the product inspected prior to use and appear to be normal? -yes.5.Introducer sheath brand name? -n/a.

Manufacturer Narrative

No device was retuned for analysis.As reported: "we have received a complaint on phoenix light support guidewire: (b)(6), lot 7931939 where the outer coating of the phoenix wire and the tip broke off inside the patient.Please let us know if you have any further questions.Thank you." initial lot history record has been concluded upon receiving the incident complaint on the (b)(6) 2024.A lot history records review was carried out on the packaged finished good lot number 7931939 and sub-assembly lots (7544152).The effected lot history records were reviewed.The reported damage is: "damaged: fracture/ shear".The guidewire lot number 7544152 was inspected on the (b)(6) 2023.Visual and tactile inspection was carried out at 100% during the production manufacture.There was also fingerpull testing on the guidewire completed at 100% inspection, and an s- 1.0 sample is taken by quality department.Break strength testing is also carried out at the end of a work order, where 2% of final good quantity is taken.The break strengths passed.The lot history records were reviewed for any temporary deviations (td's) or non- conformances (ncr's) that may have contributed to the incident.There was no deviations (td's) and no non-conformances (ncr's) applied to any finished goods.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.Review of the failure matrix analysis rsk-dfmea-000053 rev.4 was carried out and this had indicated that the risk was included, and the current controls were sufficient.The current rating for the failure mode in question is within the expected levels for the complaint.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, "excessive force used" and/or "incompatible device used" appears to have impacted on the event as reported.The risk assessment for the guidewires: mandrel product was completed using the applicable failure matrix analysis "dfmea" (rsk-dfmea-000053 rev.4).A review and summary concluded: line 253 in the aforementioned dfmea states "treatment application" notes that "fracture/ shear" potentially leads to "minor procedural delay/tissue trauma" with "excessive force used" and/or "incompatible device used" as potential root causes, with the affect as "device performance reduced due to user error".(b)(4).From risk assessment completed for this products failure mode it can be concluded that the failure mode is documented in the applicable dfmea and does not exceed the expected occurrence rate.Design mitigation activities describe for this instance: · design cannot eliminate this failure mode but may mitigate it.

• Brand Name: PHOENIX GUIDEWIRE
• Type of Device: 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: 19086357
• MDR Text Key: 340591404
• Report Number: 9681477-2024-00006
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 10845225002760
• UDI-Public: (01)10845225002760(17)260619(10)7931939
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K080144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/11/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: OFG2524LF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/14/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 100 KG