MAUDE Adverse Event Report: LAKE REGION MEDICAL PREFORM GUIDEWIRE - SAFARI2; WIRE GUIDE

Device Problems Entrapment of Device (1212); Flaked (1246); Material Deformation (2976); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2019

Event Type  malfunction  

Manufacturer Narrative

The safari2 guidewire is expected to be returned for failure analysis but was not received at the time this report was filed.Lot traceability was not provided.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.A review of the manufacturing processes indicates that during manufacturing and packaging of this product the operators are instructed to 100% visually inspect for any obvious defect prior to shipment.At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided, it appears that clinical and/or procedural factors may have contributed to the event as reported.If additional information is received or product is returned for analysis a follow-up medwatch report will be submitted.

Event Description

As reported by the distributor, patient was undergoing a transcatheter aortic valve replacement.Event description: it was reported that: recapture of second valve, wire was stuck due to overseated nosecone.Valve recaptured fine, overseating was corrected, 2nd le and safari2 were removed together because wire was stuck.Regained access with another safari2 wire.No patient complications.

Manufacturer Narrative

Device evaluation: as received, the specimen consisted of one-1 each unidentified safari2 device; returned coiled, loose and double-bagged within "zip-lock" style poly biohazard pouches.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.A review of the manufacturing processes indicates that during manufacturing and packaging of this product the operators are instructed to 100% visually inspect for any obvious defect prior to shipment.The specimen presented a mechanical shear/cut through the coil and core wires 203.35cm from the proximal end and numerous bends/kinks of varying severity and frequency scattered over the length of the device.The specimen also presented offset/overlapping coil wraps located 39.0 to 39.2cm from the proximal end creating a localized oversized diameter to.04375", and scraped, frayed and removed ptfe coating scattered over the length of the device.The offset/overlapping coil damage appeared consistent with torqueing the wire.As indicated in the device instructions for use (dfu) warnings, "do not torque this guidewire".Approximately 72cm of the distal end (including the formed distal curve) is missing and was not received with the returned specimen.It was reported by the distributor that the safari2 device was returned locked inside of the lotus edge device.The end user and the distributor's lab did not mention any missing material upon receipt and therefore this damage appears to have occurred during post event handling and prior to receiving at lake region medical for evaluation.Our investigation was unable to confirm that the product did not meet specification prior to shipment.The investigation concluded that the product met specification at the time of shipment.At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided to date, it appeared that procedural and/or clinical factors have contributed to the event as reported.If any further relevant information is provided, a follow up medwatch report will be submitted.

• Brand Name: PREFORM GUIDEWIRE - SAFARI2
• Type of Device: WIRE GUIDE
• Manufacturer (Section D): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska, mn
• MDR Report Key: 9702500
• MDR Text Key: 185701250
• Report Number: 2126666-2020-00011
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• PMA/PMN Number: K151244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 03/23/2020

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Initial Date Manufacturer Received: 01/23/2020
• Initial Date FDA Received: 02/12/2020
• Supplement Dates Manufacturer Received: 03/18/2020
• Supplement Dates FDA Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR