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

Model Number	1005203
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The additional armada 14 device is filed under separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat the left peroneal artery with right groin access.A spartacore guide wire was advanced and the 2.0x200mm armada 14 balloon catheter was advanced.There was no difficulty removing the stylet or protective sheath and the balloon was prepared/flushed prior to use.The balloon was attempted to be inflated but there was a lot of resistance.It took a lot of pressure to inflate the balloon and it was only partially inflated and not uniformly shaped.The device was losing pressure but there was no leak of contrast noted in the vessel as the balloon was inflating, nor was there any blood backfilling the inflation device so it was difficult to tell if there was a rupture.When attempting to remove the armada balloon, it became stuck with the spartacore guide wire in the superficial femoral artery and they were pulled out together, causing wire access to be lost.There was no attempt made to move the guide wire while the balloon was pressurized/inflated.The physician noted a thread of what seemed to be plastic material at the hub of the armada sheath and pulled it out without intervention.It was a long plastic material but angiography post procedure confirmed nothing remained in the patient.A command18 guide wire was advanced and a 1.5x40mm armada 14 and 2.5x200mm armada balloon catheters were used to complete the procedure.Angiogram followed revealing in line flow down to foot.There was no adverse patient effect, however, there was a delay in the procedure but no harm to the patient.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported difficult to remove was able to be confirmed.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 from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the noted damages to the armada 14 balloon catheter (inner member tear) resulted in the guide wire poking through the inner member tear resulting in the reported difficult to remove.Manipulation of the device resulted in the noted core folded back.The noted multiple core bends likely occurred due to handling or during packing for return analysis.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: HI-TORQUE SPARTACORE 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: 14735236
• Report Number: 2024168-2022-06561
• Device Sequence Number: 12273992
• Product Code: DQX
• UDI-Device Identifier: 08717648014031
• UDI-Public: 08717648014031
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K963702
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2022

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: 01/31/2024
• Device Model Number: 1005203
• Device Catalogue Number: 1005203
• Device Lot Number: 2021462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/27/2022
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2022
• 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: ARMADA 14 BALLOON CATHETER
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 67 KG