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

Model Number	1013730
Medical Device Problem Codes	Peeled/Delaminated (1454); Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer reported the device is not returning.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional device referenced in b5 is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat the iliac and renal arteries.The iliac was treated first with the command 18 (210 cm) guide wire and it was next used to treat the right and left occluded renal arteries.The command 18 (210 cm) was used with intravascular ultrasound (ivus) however there was resistance with the ivus during crossing the occluded lesion.The guide wire was continued to be used and there was resistance during removal.Next, the command 18 (210 cm) guide wire and ivus were changed to a new command 18 (300 cm) and a new ivus; however, again there was resistance with the ivus during crossing the occluded lesion.The new ivus became stuck with the command 18 (300 cm) and it was attempted to remove the ivus.During this attempt, the command 18 (300 cm) perforated the vessel when the ivus was pulled strongly.All devices were then removed and a new command 14 guide wire was used and a balloon was used to dilate the lesion and a stent was placed.The perforation was then treated by occlusion using coil and the procedure was completed.The physician stated that the command 18 (210 cm) possibly had peeling or uneven coating.Both of the command 18 guide wires (300 cm) experienced resistance and there was a possible coating issue.No additional information was provided.
Additional Manufacturer Narrative
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 incidents and/or complaint 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 difficulty to remove, and polymer peeling, or damages appear to be related to case circumstances of the procedure.In this case, based on the reported information, it is likely that during the procedure, the polymer became damaged against the anatomy and/or other devices used, resulting in the difficulty to remove.Manipulation against resistance resulted in additional polymer peeling damage and possible foreign body in the patient.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6 medical device problem code 2920 was removed.
Event or Problem Description
It was reported that the procedure was to treat the iliac and renal arteries.The iliac was treated first with the command 18 (210 cm) guide wire and it was next used to treat the right and left occluded renal arteries.The command 18 (210 cm) was used with intravascular ultrasound (ivus) however there was resistance with the ivus during crossing the occluded lesion.The guide wire was continued to be used and there was resistance during removal.Next, the command 18 (210 cm) guide wire and ivus were changed to a new command 18 (300 cm) and a new ivus; however, again there was resistance with the ivus during crossing the occluded lesion.The new ivus became stuck with the command 18 (300 cm) and it was attempted to remove the ivus.During this attempt, the command 18 (300 cm) perforated the vessel when the ivus was pulled strongly.All devices were then removed and a new command 14 guide wire was used and a balloon was used to dilate the lesion and a stent was placed.The perforation was then treated by occlusion using coil and the procedure was completed.The physician stated that the command 18 (210 cm) possibly had peeling or uneven coating.Both of the command 18 guide wires (300 cm) experienced resistance and there was a possible coating issue.Subsequent to the initially filed report, it was noted that there was no resistance during advancement of the command 18 (210 cm) device.No additional information was provided.

• 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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13181693
• Report Number: 2024168-2022-00215
• Device Sequence Number: 4315602
• Product Code: DQX
• UDI-Device Identifier: 08717648212123
• UDI-Public: 08717648212123
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K152404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2022

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: 06/30/2023
• Device Model Number: 1013730
• Device Catalogue Number: 1013730
• Device Lot Number: 1071961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/17/2021
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IVUS DEVICE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown