MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE PROGRESS 80 GUIDE WIRE

Model Number	1011838
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	11/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.It should also be noted that the reported patient effect of dissection is listed in the electronic instructions for use guide wire hi-torque progress, ptca/pta/stents, cto, ce/fda as a known patient effect of the procedure.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported the procedure was to treat a left anterior descending (lad) artery.During use of a 014 ht progress guide wire a dissection occurred; however, due to the minor extent, no treatment was necessary.The device was able to successfully complete the procedure.There was no clinically significant delay.No additional information was provided.

• Brand Name: HI-TORQUE PROGRESS 80 GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11048191
• Report Number: 2024168-2020-10774
• Device Sequence Number: 16405920
• Product Code: DQX
• UDI-Device Identifier: 08717648144103
• UDI-Public: 08717648144103
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K091825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/21/2020

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: 12/31/2021
• Device Model Number: 1011838
• Device Catalogue Number: 1011838
• Device Lot Number: 0013171
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 12/21/2020
• 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: Other