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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Arrhythmia (1721)

Event Date 07/14/2020

Event Type  Injury  

Manufacturer Narrative

Lot traceability was not provided by the end user.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 device was not received for analysis; therefore, no physical or visual analysis of the product could be performed.Review of the directions for use lists arrhythmia as a potential adverse event associated with the tavr/tavi procedure.Based on the information provided, it appears a combination of pre-existing patient conditions and clinical and/or procedural factors contributed to the event as reported.At this time, it is not possible to assign a definitive root cause for the event as reported.If any further relevant information is provided, a follow-up medwatch report will be submitted.

Event Description

Patient was found to have 1°avb before the procedure.Abnormal ecg was observed before the procedure, so the physician pointed out that the possibility of transition to cavb after the procedure was high risk.During the procedure, it proceeded without problem.18mm balloon was used, and pre-bav was performed under rapid pacing.Rapid pacing was turned off, but self-pulse restored naturally.Lotus edge implantation was completed with no pvl and without repositioning.During the procedure, pvc was observed several times due to guidewire, but electrocardiographic changes other than that were not observed.Patient returned to room without performing pacing.The following day, the physician reported that cavb symptoms appeared from the night of the procedure, so pacing was started.The day after the procedure, cavb was observed on the electrocardiogram, so it was judged to adapt pmi.Additional information received indicates that the safari2 wire did not cause or contribute to the cavb that occured post procedure.The patient's current condition was reported as good.

• Brand Name: PREFORM GUIDEWIRE - SAFARI2
• Type of Device: WIRE GUIDE
• Manufacturer (Section D): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska, mn
• Manufacturer (Section G): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska, mn
• Manufacturer Contact: sharon seifert ; 340 lake hazeltine drive; chaska, mn ; 6418518
• MDR Report Key: 10413369
• MDR Text Key: 204598795
• Report Number: 2126666-2020-00055
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2020
• 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 Outcome(s): Other
• Patient Age: 70 YR
• Patient Weight: 65