MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE INFILTRAC; WIRE, GUIDE, CATHETER

Model Number	1030003J
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot specific quality issue.There is no indication of a product quality issue with respect to manufacture, design or labeling.The investigation determined that it is likely case circumstances that resulted in the reported difficulty to remove.Based on the reported information, it is likely as noted due to patient anatomy the device became difficult to remove.There is no indication of a product quality issue with respect to manufacture, design or labeling.The first infiltrac guide wire referenced is being filed under a separate medwatch report #.
Event or Problem Description
This is being filed on the second infiltrac guidewire used in this patient.It was reported that this was a percutaneous coronary intervention to treat a chronic total occlusion (cto) in the mid left anterior descending (lad) coronary artery during a physician preference testing.The infiltrac guide wire successfully penetrated the cto lumen.During removal of the infiltrac guide wire, it was difficult to remove due to the patient anatomy.After removal of the wire from the non-abbott balloon dilatation catheter (bdc), contrast was noted to be staining on the fluoroscopy, signaling a ruptured bdc.The physician suspects that the tip of the infiltrac guide wire caused the balloon rupture.After removal of the guide wire, there was no damage noted to the guide wire.Another infiltrac was used to complete the procedure.The second infiltrac was also difficult to retract, but it was removed without incident.There were no adverse patient effects and no clinically significant delay in the procedure.There was no additional information provided.

• Brand Name: HI-TORQUE INFILTRAC
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10715515
• Report Number: 2024168-2020-08831
• Device Sequence Number: 11739225
• Product Code: DQX
• UDI-Device Identifier: 08717648233715
• UDI-Public: 08717648233715
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K193126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 1030003J
• Device Catalogue Number: 1030003J
• Device Lot Number: 0032361
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 10/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1