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

Model Number H74939406S1

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 12/16/2020

Event Type  Injury  

Manufacturer Narrative

This medwatch report is being filed based on the report that the adverse event may have been caused by the safari2 guidewire.It was reported that no product is expected to be returned for evaluation.Maly that could have impacted on the event as reported.A review of the device history records of the specimen device does 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 defect prior to shipment.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.As indicated in the device instructions for use (dfu) warnings section, "when advancing or removing the guidewire, always use fluoroscopic guidance with radiographic equipment that provides high-resolution images.Never position the guidewire blindly, as this may result in misplacement, dissection or perforation." 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 impacted on the event as reported.If there is any further relevant information provided, a follow up medwatch report will be submitted.

Event Description

Per email, it was reported that: attempted to close a failed surgical ligation.Transeptal was done, a double curve lot 26266917 was inserted into left atrium.The md chose to use a 4french cordis catheter to help navigate into the small ostia.He then chose a safari 2 wire lot 11209610 to hold position is the laa in order to navigate the was into the ostia.This was attempted and it appeared the was was in the ostia, once the cordis catheter and the safari were pulled the sheath was noted on echo to not be in the laa.The md attempted the same maneuver again, upon doing a contrast injection this time it was noted on fluoro that the wire had perforated the wall of the laa.200 pro taming was given, the patients bp dropped, the chest was prepped for pericardiocentesis and surgeons were called.The patient began to stabilize, not pericardiocentesis was performed, the surgeon and doctor agreed it best to watch the patient overnight and not intervene.*baseline trivial effusion was noted at start of procedure, trivial effusion never changed on tee, transverse sinus fluid status did increase post perforation but normalized.Pt went to room in stable condition.

• 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: 11132736
• MDR Text Key: 231244558
• Report Number: 2126666-2021-00002
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08714729887591
• UDI-Public: 08714729887591
• 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
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: H74939406S1
• Device Catalogue Number: 39406S1
• Device Lot Number: 11209610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2020
• 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: 85 YR