MAUDE Adverse Event Report: LAKE REGION MEDICAL PREFORM GUIDEWIRE - SAFARI; WIRE GUIDE

Lot Number UNKNOWN

Device Problems Flaked (1246); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2018

Event Type  malfunction  

Manufacturer Narrative

Reportable based on analysis of the returned specimen.The lack of lot traceability prevents performing a device history records review for any indication of manufacturing defect or anomaly that could have impacted on the event as reported.One unknown safari guidewire was returned for analysis.The specimen presented a fracture of the core wire near the distal end, stretched coil wraps, mis-aligned, offset and overlapping coil wraps creating localized oversized diameters to.04185", and numerous kinks/bends of varying frequency and severity.Upon receipt of permission, the coil wraps approximately 14.5cm from the distal tip and those adjacent to the distal tip were stretched to expose both aspects of the core wire fracture located immediately proximal of the distal tip weld mass.The fracture presented indications of ductile, tensile overload.The specimen also presented ptfe coating damage; including coating removal and scraped/frayed coating.Except where noted, the specimen device appeared visually and dimensionally correct for a safari wire 300cm sml crv device.None of the associated devices involved in the reported event were returned with the specimen safari wire.The nature and extent of the damage presented appears consistent with occurring during the clinical event as described in the complaint narrative: "physician moved the ds with the loaded valve and the isleeve with a lot of force" and "physician opinion of relationship of event to device or the index procedure: dr._ said it was probably a kink in the safari wire due the tortuous anatomy of the patient".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, clinical and/or procedural factors appear to have impacted on the event as reported.If additional information is received, including lot traceability, a follow-up medwatch report will be submitted.

Event Description

As reported by the distributor: it was reported that: safari wire, isleeve were on place, the valve was loaded by ifu.After inserting the valve through the isleeve, the delivery system was stuck and would not move anymore.Physician moved the delivery system with the loaded valve and the isleeve with a lot of force.He exchanged the wire.For the second attempt they used a lis-s and a new accurate neo and a new delivery system.No patient harm.Physician opinion of relationship of event to device or the index procedure: physician said it was probably a kink in the safari wire due the tortuous anatomy of the patient.

• Brand Name: PREFORM GUIDEWIRE - SAFARI
• Type of Device: WIRE GUIDE
• Manufacturer (Section D): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: jackie ohnsorg ; 340 lake hazeltine drive; chaska, MN 55318 ; 9526418516
• MDR Report Key: 8226308
• MDR Text Key: 133956149
• Report Number: 2126666-2019-00003
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K130798
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/08/2019

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
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/31/2018
• Initial Date FDA Received: 01/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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: 85 YR