MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE COMMAND 14 GUIDE WIRE

Catalog Number 2078175

Device Problems Peeled/Delaminated (1454); Difficult to Remove (1528); Stretched (1601); Difficult to Advance (2920)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/12/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional command guide wire referenced in b5 is filed under separate medwatch report number.

Event Description

It was reported that the procedure was to treat a lesion in the lower extremity with calcification.Two hi-torque (ht) command 14 guide wires had resistance during advancement with the anatomy and were noted to have the distal part/polymer coating noted to have peeled during recanalization and upon removal of the guide wires, however, there was no separation.It was fully retrieved without any intervention performed.There was no adverse patient effect and there was no clinically significant delay in the procedure.Another ht command guide wire was used to complete the procedure.No additional information was provided.

Event Description

It was reported that the procedure was to treat a lesion in the lower extremity.Two hi-torque (ht) command 14 guide wires were noted to have the distal part/polymer coating separated from the core.It is unknown if the separated portion was left in the anatomy.There was no reported adverse patient sequelae and there was no reported clinically significant delay in the procedure.Subsequent to the initially filed mdr, the following information was provided: the lesion was moderately calcified.There was resistance during advancement with the anatomy.There was some resistance when initially trying to remove the guide wires.There was no way to remove the guide wires directly from the catheter.The guide wires had to be torqued and manipulated with a little push and pull to get the guide wires out in one piece.The coating was noted to have peeled during recanalization and upon removal of the guide wires, however, there was no separation.It was noted the guide wires got extended [stretched] and peeled.They were fully retrieved without any intervention performed.Another ht command guide wire was used to complete the procedure.No additional information was provided.Return device analysis identified that the polymer coating was separated for the two hi-torque (ht) command 14 guide wires and not returned.Therefore, there is the potential that the separated polymer coating may remain in the patient anatomy.

Manufacturer Narrative

A visual inspection was performed on the returned device.The reported stretched coils was confirmed.The reported peeled/delaminated was confirmed as material separation.The reported difficulty to advance and difficult to remove could not be tested due to device condition.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/complaints from this lot.The investigation determined the reported difficulties and treatment appear to be related to the operational context of the procedure.Return device analysis identified that the separated polymer coating was not returned.Therefore, there is the possibility that the separated polymer remains in the patient anatomy.In this case, in was reported that the guide wire interacted with the moderately calcified lesion during advancement, resulting in the reported difficult to advance.Additionally, it was reported that the polymer peeling occurred during recanalization, suggesting interaction with the calcified anatomy or an accessory device contributed to the reported polymer damage.Polymer damage would likely impact the guide wires maneuverability through the guide catheter, contributing to the reported resistance during removal.Additionally, it was noted that the guide wire was manipulated when attempting to remove it from the catheter.Manipulation of the wire against resistance likely contributed to further polymer damage, the noted core separation, and stretched coils.There is no indication of a product quality issue with respect to manufacture, design, or labeling.B1 - adverse event/product problem updated to adverse event and product problem.B2 - outcomes attributed to ae updated from na to other serious.H6: health effect - clinical code 4582 removed and 2687 added.H6: health effect - impact code 2199 removed and 4614 added.

• Brand Name: HI-TORQUE COMMAND 14 GUIDE WIRE
• Type of Device: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005737652; road no.2 km 58.0 cruce dávila; barceloneta PR 00617
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 18426670
• MDR Text Key: 331926880
• Report Number: 2024168-2024-00005
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K122573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2078175
• Device Lot Number: 3042471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other