MAUDE Adverse Event Report: ABBOTT VASCULAR HT COMMAND 14; GUIDE WIRE

Model Number	2078174
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920); Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a lesion below the knee.When the procedure was completed and the ht command guide wire was removed, the distal tip had a loop and the last 2 cm of the tip had separated and remained in the patient anatomy.There was no reported treatment.There was no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual and dimensional inspections were performed on the returned guide wire, and the reported separation was confirmed.The reported prolapse, difficulty to advance/position and difficulty to remove were 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 incidents and/or complaint reported from this lot.There was no damage noted to the guide wire during the inspection prior to preparation of the wire which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.
Event or Problem Description
Additional reported information indicates that the procedure was to treat a 90% stenosed lesion in the tortuous anterior tibial artery.Resistance was noted with the anatomy and guiding catheter during advancement, and resistance with the anatomy was noted during withdrawal.The guide wire was prolapsed until it reached the occlusion.The tip was not removed and a portion remains stuck in the vessel.

• Brand Name: HT COMMAND 14
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9653590
• Report Number: 2024168-2020-01079
• Device Sequence Number: 19438672
• Product Code: DQX
• UDI-Device Identifier: 08717648176678
• UDI-Public: 08717648176678
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K122573
• 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,Followup
• Report Date (Section B): 03/31/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 2078174
• Device Catalogue Number: 2078174
• Device Lot Number: 9080871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 01/31/2020
• Supplement Report FDA Received Date: 03/31/2020
• 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