MAUDE Adverse Event Report: ABBOTT VASCULAR ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE

Model Number	1001780J
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a situ at point of elbow (via radial access).A balloon initially passed on the guide wire without complications, but then became stuck at the solder point of the guide wire.After pulling out the guide wire from the anatomy, it was noted there was a palpable lump on the solder point of the wire.Solder point appeared to expand with body heat.The account confirmed there was no device separation or peeling of the coating.Another bmw guide wire was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation determined the reported difficult to remove appears to be related to the operational context of the procedure; however, the investigation was unable to determine a conclusive cause for the reported material deformation.There is no indication of a product quality issue with respect to manufacture, design, or labeling of the device.D9, h3: device status changed from returning to not returned.
Additional Manufacturer Narrative
A visual and dimensional inspection, in addition to a chem analysis was performed on the returned device.The reported material deformation was confirmed.The reported difficult to advance sds, difficult to advance balloon, and difficult to remove balloon could not be tested due to the device condition.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents from this lot.A chem analysis was performed on the unknown blue material discovered during return analysis: the analysis stated that the white fiber clump is polyester net and the blue material resembles cellulose fiber.The investigation was unable to determine a conclusive cause for the reported difficulties.In this case, it is possible that interaction between the guide wire and the patient¿s anatomy or an accessory device may have contributed to the noted deformation due to compressive stress (kinked core), subsequently resulting in the reported difficult to advance sds, difficult to advance balloon, and difficult to remove balloon.Manipulation of the guide wire during its interaction with the sds/balloon possibly resulted in the noted material deformation (misaligned coils) and stretched coils.Additionally, the unknown fibers and blue material returned with the device is possibly from an accessory device; however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling of the device.D9, h3 - device status return changed from not returned to returned.H6 - type of investigation code 4114 was removed.
Event or Problem Description
It was reported that the procedure was to treat a situ at point of elbow (via radial access).A balloon initially passed on the guide wire without complications, but then became stuck at the solder point of the guide wire.After pulling out the guide wire from the anatomy, it was noted there was a palpable lump on the solder point of the wire.Solder point appeared to expand with body heat.The account confirmed there was no device separation or peeling of the coating.Another bmw guide wire was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Subsequent to the initially filed mdr report, the account confirmed additional information.The bmw guide wire was placed at the lesion.However, a stent delivery system and balloon catheter were unable to pass the solder point of the guide wire.No additional information was provided.

• Brand Name: ACS HI-TORQUE BALANCE MIDDLEWEIGHT 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: 14982663
• Report Number: 2024168-2022-07517
• Device Sequence Number: 5098534
• Product Code: DQX
• UDI-Device Identifier: 08717648025976
• UDI-Public: 08717648025976
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K021228
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/24/2022

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: 12/31/2023
• Device Model Number: 1001780J
• Device Catalogue Number: 1001780J
• Device Lot Number: 2011871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 08/29/2022; 10/14/2022
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 09/08/2022; 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2022
• 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
• Patient Sex: Unknown