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

Model Number	2078173
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2021, the patient presented with monckeberg sclerosis in the aorta with runoff in peripheral vessels and heavy calcification.That day, a percutaneous intervention was performed on the right popliteal and right superficial femoral artery (sfa) containing this heavy/jagged calcification.Using a 6 french sheath, an ht command guide wire advanced through the acute/steep iliac bifurcation without issues.Following, an armada 18 and an armada 35 balloon dilatation catheter had advanced without issues.Upon first inflation attempt, both balloons had ruptured below rated burst pressure due to the heavy, jagged calcification.The catheters were removed without issue and another device was used in replacement.The first supera stent was successfully implanted.Following, a second supera stent delivery advanced with difficulty/resistance noted with the command wire, once at the steep bifurcation.The supera had then become stuck on the wire and was unable to advance or be removed.Both were removed as a single unit (the wire and supera sds).Another device was used in replacement, completing the procedure, without further issues noted.There were no adverse patient effects and there was no clinically significant delay.No additional information was provided regarding this issue.
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The supera stent delivery system and armada catheters referenced are being filed under separate medwatch report numbers.
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The supera stent delivery system and armada catheters referenced are being filed under separate medwatch report numbers.
Event or Problem Description
It was reported that on (b)(6) 2021, the patient presented with monckeberg sclerosis in the aorta with runoff in peripheral vessels and heavy calcification.That day, a percutaneous intervention was performed on the right popliteal and right superficial femoral artery (sfa) containing this heavy/jagged calcification.Using a 6 french sheath, an ht command guide wire advanced through the acute/steep iliac bifurcation without issues.Following, an armada 18 and an armada 35 balloon dilatation catheter had advanced without issues.Upon first inflation attempt, both balloons had ruptured below rated burst pressure due to the heavy, jagged calcification.The catheters were removed without issue and another device was used in replacement.The first supera stent was successfully implanted.Following, a second supera stent delivery advanced with difficulty/resistance noted with the command wire, once at the steep bifurcation.The supera had then become stuck on the wire and was unable to advance or be removed.Both were removed as a single unit (the wire and supera sds).Another device was used in replacement, completing the procedure, without further issues noted.There were no adverse patient effects and there was no clinically significant delay.No additional information was provided regarding this issue.
Additional Manufacturer Narrative
Visual, dimensional, and functional inspections were performed on the returned guide wire.The reported difficulty to advance was confirmed.The reported difficulty to remove from the self-expanding stent delivery system (sess) was unable to be confirmed due to the returned condition of the devices.Additionally, it was noted that there was scratches sporadically throughout the entire length of the teflon coating.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 complaints reported from this lot.Factors that may contribute to the difficulty to advance/position and remove the guide wire and cause resistance between the devices may include, but not limited to, manufacturing, device placement technique, guiding catheter support, anatomical conditions/patient anatomical morphology, inner diameter of guide wire lumen or delivery device, outer diameter of the guide wire, condition of the guide wire, condition of the delivery device, coagulation of blood or procedural contaminates.The investigation was unable to determine a conclusive cause for the reported difficulty to advance and remove from a sess.The noted teflon coating damage likely occurred during retraction through the torque device used in the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: HI-TORQUE COMMAND 14 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 # 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: 13019367
• Report Number: 2024168-2021-11679
• Device Sequence Number: 4803200
• Product Code: DQX
• UDI-Device Identifier: 08717648176661
• UDI-Public: 08717648176661
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K122573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2022

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: 12/31/2022
• Device Model Number: 2078173
• Device Catalogue Number: 2078173
• Device Lot Number: 1011371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2021
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2021
• 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: IMPLANTED SUPERA X1; SUPERA STENT DELIVERY SYSTEM
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 46 KG