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

Model Number H74939406XS1

Device Problems Flaked (1246); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2020

Event Type  malfunction  

Manufacturer Narrative

Reportable based on analysis of the returned specimen exhibiting ptfe coating damage and removal.Lot traceability was provided.A review of the device history records of the specimen device did not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.During manufacturing and packaging of this product the operators are instructed to 100% visually inspect for any obvious defects prior to shipment.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.One-1 each safari2 275cm x sml crv; was returned coiled, loose and double-bagged within "zip-lock" style poly biohazard pouches.The returned specimen presented a dim "a" length of 275.70cm, formed curve dimensions 2.70cm x 3.25cm, and a finished diameter of.03455" to.03460".The returned specimen presented multiple offset/overlapping coil wraps scattered over the length of the device, creating localized oversized diameters to.03945", and scraped ptfe coating with removal on and near the offset/overlapping coil wraps.The specimen also presented large radius bends near each end and dried blood-like material on and between the coil wraps.The offset/overlapping coil damage appeared consistent with torquing the wire.As indicated in the device instructions for use (dfu) warnings, "do not torque this guidewire".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 and the evidence presented, it appeared that clinical and/or procedural factors have contributed to the event as reported.

Event Description

As reported: event description: per email, it was reported that: at the account.The physicians were performing a lotus edge implant (23 mm lot# 24743866) with an extra small safari2 wire ( lot# 11209611).The lotus edge device was advanced over the wire and the nosecone into the isleeve ( lot #24727442) when it was unable to advance.A kink was suspected and the lotus edge device was removed off of the wire.A pigtail catheter was then advanced over the wire and into the left ventricle and the safari wire was removed and exchanged for a new safari wire.The lotus edge device was then successfully advanced over the new wire and the procedure was successful.Upon inspection of the wire in question, it appears as if the coating on the wire had rubbed off.

Manufacturer Narrative

This is a follow-up to the previous medwatch report sent on 01-jul-2020.Additional information was received.Reportable based on analysis of the returned specimen exhibiting ptfe coating damage and removal.Lot traceability was provided.A review of the device history records of the specimen device did not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.During manufacturing and packaging of this product the operators are instructed to 100% visually inspect for any obvious defects prior to shipment.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.One-1 each safari2 275cm x sml crv; was returned coiled, loose and double-bagged within "zip-lock" style poly biohazard pouches.The returned specimen presented a dim "a" length of 275.70cm, formed curve dimensions 2.70cm x 3.25cm, and a finished diameter of.03455" to.03460".The returned specimen presented multiple offset/overlapping coil wraps scattered over the length of the device, creating localized oversized diameters to.03945", and scraped ptfe coating with removal on and near the offset/overlapping coil wraps.The specimen also presented large radius bends near each end and dried blood-like material on and between the coil wraps.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".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 and the evidence presented, it appeared that clinical and/or procedural factors have contributed to the event as reported.

Event Description

As reported: event description: per email, it was reported that: at the account.The physicians were performing a lotus edge implant (23 mm lot# 24743866) with an extra small safari2 wire ( lot# 11209611).The lotus edge device was advanced over the wire and the nosecone into the isleeve ( lot #24727442) when it was unable to advance.A kink was suspected and the lotus edge device was removed off of the wire.A pigtail catheter was then advanced over the wire and into the left ventricle and the safari wire was removed and exchanged for a new safari wire.The lotus edge device was then successfully advanced over the new wire and the procedure was successful.Upon inspection of the wire in question, it appears as if the coating on the wire had rubbed off.Additional information received after initial medwatch was filed: were exactly was the kink located? no kink was observed but the appearance of the coating of the wire had been rubbed off.Were there difficulties removing the le over the damaged safari or isleeve? there was difficulty removing the le over the safari wire but they were eventually able to without losing the wire position in the heart.There was no damage to isleeve.Did the end user notice any resistance during loading the pigtail catheter over the safari2 wire prior to removal? the physicians did not mention any resistance with the pigtail.Patient status? patient was discharged home.

• 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: 10218159
• MDR Text Key: 197563316
• Report Number: 2126666-2020-00045
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08714729887614
• UDI-Public: 08714729887614
• 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: 07/16/2020

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
• Device Expiration Date: 01/31/2023
• Device Model Number: H74939406XS1
• Device Catalogue Number: 39406XS1
• Device Lot Number: 11209611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Initial Date Manufacturer Received: 06/16/2020
• Initial Date FDA Received: 07/01/2020
• Supplement Dates Manufacturer Received: 06/16/2020
• Supplement Dates FDA Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR