MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE COMMAND 18 GUIDE WIRE

Model Number	1013753
Medical Device Problem Codes	Product Quality Problem (1506); Difficult to Remove (1528); Difficult to Advance (2920); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	10/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight was estimated.The device is expected to be returned for evaluation.It has not yet been received.A follow report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the hi-torque command 18 lt guidewire was used to place a cardiomems sensor.Resistance was noted with the catheter during advancement and removal.When the wire was pulled out of the catheter, it was rough and frayed.Per the physician, the wire caused the catheter to have a clot.Treatment, if any, was not reported.The sensor was implanted without issue and is functioning as it should.There was no adverse patient sequela reported.No additional information was provided.
Event or Problem Description
It was reported that the hi-torque command 18 lt guidewire was used to place a cardiomems sensor.Resistance was noted with the catheter during advancement and removal.When the wire was pulled out of the catheter, it was rough and frayed.Per the physician, the wire caused the catheter to have a clot.Treatment, if any, was not reported.The sensor was implanted without issue and is functioning as it should.There was no adverse patient sequela reported.No additional information was provided.Subsequent to filing the initial report, the following information was provided.The patient did not receive additional medication or treatment due to the clot; however, their normal medication was started again.
Additional Manufacturer Narrative
Visual and dimensional analysis was performed on the returned device.The material fray and torn were confirmed.The failure to advance and difficult to remove were confirmed using an armada 18 as a proxy device since the cardiomems device 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.Additionally, a review of the complaint history identified no indication to suggest a lot specific product issue exists.Based on the information provided, the investigation was unable to determine a conclusive cause for the reported product quality issue (fray), difficult to advance, difficult to remove and material split or tear resulting in thrombosis.The wire may have been damaged during the insertion process or it may be possible that during use, the clearance between the guide wire and the cardiomems catheter was reduced causing the devices to become stuck together, resulting in the catheter inability to advance and the subsequent difficult to remove, however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.

• Brand Name: HI-TORQUE COMMAND 18 GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10809486
• Report Number: 2024168-2020-09319
• Device Sequence Number: 3799566
• Product Code: DQX
• UDI-Device Identifier: 08717648211980
• UDI-Public: 08717648211980
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K152404
• 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): 01/18/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 1013753
• Device Catalogue Number: 1013753
• Device Lot Number: 0031761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 01/18/2021
• 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: CARDIOMEMS; SWAN/PULMONARY CATHETER; CARDIOMEMS; SWAN/PULMONARY CATHETER
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 79