MAUDE Adverse Event Report: ABBOTT VASCULAR HT PILOT; GUIDE WIRE

Catalog Number	1010485-H
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.The device was received.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 laser atherectomy was performed over the hi torque pilot guide wire in the chronic total occlusion (cto) in the right coronary artery (proximal to distal segments were cto) and the procedure was complete.The laser atherectomy device was removed from the guide wire and the patient.When attempt was made to remove the pilot guide wire, it retracted a little, but then became stuck.The guide wire was re-advanced and was then simultaneous removed as a unit with the non-abbott corsair microcatheter that was already in place.Once the devices were removed outside the anatomy, the physician was able to remove the guide wire from the microcatheter using a lot of force; there was a lot of resistance.He then noted that either the coating or the coils of the guide wire were frayed and bunched up.In the opinion of the physician, it is possible that the heat from the laser atherectomy may have contributed to the device issue of the guide wire.There were no adverse patient effects.There was no clinically significant delay in the procedure as this was the end of the case.No additional information was provided.
Additional Manufacturer Narrative
Visual and dimensional inspections were performed on the returned guide wire, and the reported polymer damages were confirmed.The reported difficult to remove form a guiding catheter was unable to be confirmed due to the polymer damages.The reported difficulty to remove from the anatomy was unable to be replicated in a testing environment as it was based on operational circumstances.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 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 difficulties appear to be related to operational circumstances of the procedure.During the procedure, the heat from laser atherectomy device likely caused the polymer coating to weaken and/or caused damage resulting in the polymer damages and the difficulties during retraction through the anatomy and micro-catheter.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: HT PILOT
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9134755
• Report Number: 2024168-2019-12194
• Device Sequence Number: 14094138
• Product Code: DQX
• UDI-Device Identifier: 08717648073953
• UDI-Public: 08717648073953
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101116
• 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,Followup
• Report Date (Section B): 11/26/2019

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: 05/31/2021
• Device Catalogue Number: 1010485-H
• Device Lot Number: 9060371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Initial Date Received by Manufacturer: 09/06/2019
• Supplement Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 11/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CORSAIR MICROCATHETER; LASER ATHERECTOMY