MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC TEMPORARY PACING GUIDEWIRE, 1PK; CATHETER GUIDEWIRE

Catalog Number	2250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that by clinical staff at the hospital: "the device was used on a tavr procedure.Patient left the room and was stable.The physician saw the patient the next day and she was in good spirits ready to be discharged.30 minutes later she coded.They did cpr and brought her back to the cath lab.It was an apparent effusion, so they cracked her chest on the table and the cardiothoracic surgeon saw there was a small hole in the ventricle.She subsequently died." other relevant additional information provided by clinical staff at the hospital: "there was no issues or complications with delivering the wire during the procedure.There was no damage noted to the tip of the device after the procedure.The effusion was not present after the tavr deployment.The patient became hypotensive prior to coding.The physician said that this would have happened with any wire he would have used, they felt that the wattson was not at fault.".
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported initially by clinical staff at the hospital: "the device was used on a tavr procedure.Patient left the room and was stable.The physician saw the patient the next day and she was in good spirits ready to be discharged.30 minutes later she coded.They did cpr and brought her back to the cath lab.It was an apparent effusion, so they cracked her chest on the table and the cardiothoracic surgeon saw there was a small hole in the ventricle.She subsequently died." additional information provided by clinical staff at the hospital: "there was no issues or complications with delivering the wire during the procedure.There was no damage noted to the tip of the device after the procedure.The effusion was not present after the tavr deployment.The patient became hypotensive prior to coding.The physician said that this would have happened with any wire he would have used, they felt that the wattson was not at fault.".
Additional Manufacturer Narrative
(b)(4).No return product evaluation could be completed as the device was not returned for investigation.The top-level assembly traveler (rt106765, lot 730841) was reviewed.There are no dda's, nce's or any other nonconformances related to this lot therefore supporting the device met material, assembly and performance specifications.Case details were reviewed.A patient underwent a transcatheter aortic valve replacement (tavr).The physician saw the patient the next day and she was in good spirits ready to be discharged.30 minutes later she coded.They did cpr and brought her back to the cath lab.It was an apparent effusion, so they cracked her chest on the table and the cardiothoracic surgeon saw there was a small hole in the ventricle.She subsequently died.As per the additional information received, procedure was performed on sep 25th, 2024, medtronic valve was used.No issues observed with the delivery guidewire (wattson).No tip or shaft damages noted.No deliverability issues noted.Effusion was not present post tavr deployment.Hypotension was observed 24 hours later.Patient was transferred for open heart surgery.Small hole observed in the ventricle.Per ifu, left ventricular perforation is identified as a potential adverse effect that may be associated with the use of temporary pacing guidewire.Per reporting physician, the issue could have happened with any valve delivery wire.Wattson was not at fault.Case details were reviewed with tfx cma.Per cma, lv perforation/laceration is a known and sometimes catastrophic event during tavr and is most often understood to be consequent to the large forces translated to the pre-shaped spiral section of the delivery wire by the "nose" of the tavr delivery system.No procedural or surgery notes were shared.No autopsy report and angiograms were provided.Patient died on sep 26th, 2024.Cause of death was effusion.A manufacturing record review was completed for lot 730841 and no related nonconformances were found.Based on the information, the most likely root cause of the issue is undeterminable.The der process will continue to monitor for any similar events.

• Brand Name: TEMPORARY PACING GUIDEWIRE, 1PK
• Common Device Name: CATHETER GUIDEWIRE
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC; minneapolis MN
• Manufacturer (Section G): VASCULAR SOLUTIONS LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20587593
• Report Number: 2134812-2024-00053
• Device Sequence Number: 6558814
• Product Code: DQX
• UDI-Device Identifier: 10841156108885
• UDI-Public: (01)10841156108885(11)240423(17)260423(10)730841(21)
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K192454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/23/2026
• Device Catalogue Number: 2250
• Device Lot Number: 730841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Outcome Attributed to Adverse Event: Life Threatening; Death
• Patient Age: 86 YR
• Patient Sex: Female