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

Model Number	1030001J
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product performance engineering reviewed the incident information; however, the product was not returned to abbott vascular 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 identified no other similar incidents and/or complaints reported from this lot.There was no damage noted to the guide wire during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.The investigation determined the reported difficult/delayed positioning or visibility issues appear to be related to operational circumstances of the procedure.Based on the reported information, it is likely that the totally occluded anatomy caused the positioning and visibility issues.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat a totally occluded circumflex vessel (lcx).A hi-torque infiltrac guide wire was advanced to the end of a non-abbott microcatheter; however, the guide wire was only advanced 1-2 cm past the tip of the microcatheter as the tip could not be adequately seen under fluoroscopy to place in the ostium of the circumflex vessel.The guide wire was removed.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was 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: 10685470
• Report Number: 2024168-2020-08635
• Device Sequence Number: 13595952
• Product Code: DQX
• UDI-Device Identifier: 08717648233692
• UDI-Public: 08717648233692
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 10/15/2020

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: 1030001J
• Device Catalogue Number: 1030001J
• Device Lot Number: 0032061
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 10/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1