MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE FLOPPY II GUIDE WIRE WITH MICROGLIDE COATING

Model Number	22339M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Vascular Dissection (3160)
Date of Event	03/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified right coronary artery.During use of a.014 ht floppy guide wire, it perforated a vessel.However, it is unknown when the perforation occurred; if during advancement or removal.The perforation was treated with an unspecified stent.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
There was no reported device malfunction and the product was not returned.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of perforation is listed in the instructions for use guide wire hi-torque guide wires, ce/ fda, as a known adverse event/patient effect of the procedure.A conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined.Additionally, the treatment appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified right coronary artery.During use of a.014 ht floppy guide wire, it perforated a vessel.However, it is unknown when the perforation occurred; if during advancement or removal.The perforation was treated with an unspecified stent.There was no adverse patient sequela and no clinically significant delay.Subsequent to filing the initial report, the following additional information was received: the ht floppy guide wire perforated a tiny branch off the circumflex during advancement.No additional information was provided.

• Brand Name: HI-TORQUE FLOPPY II GUIDE WIRE WITH MICROGLIDE COATING
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11665046
• Report Number: 2024168-2021-03118
• Device Sequence Number: 3128517
• Product Code: DQX
• UDI-Device Identifier: 08717648080098
• UDI-Public: 08717648080098
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K913353
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2021

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: 09/30/2022
• Device Model Number: 22339M
• Device Catalogue Number: 22339M
• Device Lot Number: 0100661
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR