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

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

This is a follow-up to the previous medwatch report.Additional information was added of this medwatch report.The safari2 guidewire is not expected to be returned for failure analysis.Without return of the actual device in question for evaluation, lake region medical is unable to determine the exact cause for this incident.Additionally, no lot traceability was 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.Review of the process 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 complaint is non-verifiable as the product was not returned for evaluation.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 have contributed to the event as reported.If additional information is received or product is returned for anaylsis a follow-up medwatch report will be submitted.

Manufacturer Narrative

The safari2 guidewire is not expected to be returned for failure analysis.Without return of the actual device in question for evaluation, lake region medical is unable to determine the exact cause for this incident.Additionally, no lot traceability was 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.Review of the process 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 complaint is non-verifiable as the product was not returned for evaluation.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 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

Event description: per email, it was reported that: guide wire stuck in delivery system.During the index procedure, while inserting the unknown size lotus edge valve, the guide wire was stacked into the delivery system.The wire was cut and removed from the body.-no adverse event associated with the device deficiency was reported.The same day of the index procedure, post tavr, the subject was noted with left bundle branch block.No diagnostic was performed, and no action was taken for the event.At the time of reporting, the event was considered recovering/ resolving.Potential relationship to the study procedure as per investigator: causal relationship.

• Brand Name: PREFORM GUIDEWIRE - SAFARI2
• 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: 9526185
• MDR Text Key: 185103983
• Report Number: 2126666-2019-00093
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 71 YR