MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC SPECTRE GUIDEWIRE; CATHETER

Model Number	7386
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	10/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing record was reviewed, there were no nonconformance related to this lot, therefore, supporting the device met material, assembly and performance specifications.A follow-up report will be issued after the investigation is complete.
Event or Problem Description
As reported: at the completion of the successful index procedure on cto pci study it was noted that there was a small (ellis grade ii) distal wire perforation in the plv branch caused by the spectre wire.Perforation treated with 30-minute prolonged balloon occlusion with no residual perforation noted.All coronary equipment/devices removed, and protamine was administered to reverse anticoagulation.Bedside echocardiogram showed no effusion.This event was resolved with no sequelae on (b)(6) 2020.Subject discharged to home on (b)(6) 2020 in good condition.
Additional Manufacturer Narrative
A returned product evaluation was not completed, without product evaluation, it is undeterminable if any damages were present on the guidewire.It is unlikely that guidewire was manipulated without fluoroscopy.Per ifu it states "when the guidewire is in the body, it should be manipulated only under fluoroscopy.Do not attempt to move the guidewire without observing the resultant tip response, as guidewire damage or vessel injury may occur.Vessel perforation had been identified as a potential adverse event in the ifu.Based on the limited information and no product evaluation,the most likely root cause of the issue is undeterminable.

• Brand Name: SPECTRE GUIDEWIRE
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 11010925
• Report Number: 2134812-2020-00099
• Device Sequence Number: 4496741
• Product Code: DQX
• UDI-Device Identifier: 10841156101138
• UDI-Public: (01)10841156101138
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K163444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2020

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: 03/13/2022
• Device Model Number: 7386
• Device Catalogue Number: 7386
• Device Lot Number: 669685
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 03/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 79