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

Catalog Number	1009666J
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	12/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported during the procedure was to treat a mildly tortuous anterior descending artery.The ht balance middleweight universal ii guide wire was already in position and unspecified balloon could not longer progress nor retract; therefore, the entire assembly was removed.Once removed, part of the teflon coating had peeled off and cannot be confirmed if any coating was left in the patient.Another guidewire was used to complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned 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 of the reported lot did not indicate a lot specific quality issue.The investigation was unable to determine a conclusive cause for the reported difficulties; however, the subsequent patient effect appears to be related to operational context.It is unconfirmed if a portion or the teflon remains within the anatomy.There is no indication of a product quality issue with respect to manufacture, design, or labeling.D9, h3: device returning status updated from yes to "no".
Additional Manufacturer Narrative
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 of the reported lot did not indicate a lot specific quality issue.D4 - catalog number updated from 1009667j to 1009666j.D4 - udi number updated to (b)(4).
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned device.The reported peeled/delaminated was confirmed.The reported difficult to advance and difficult to remove could not be tested due to the 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 of the reported lot did not indicate a lot specific quality issue.The investigation determined the reported difficulties and the subsequent patient effect appear to be related to operational context.It is unconfirmed if a portion or the teflon remains within the anatomy.It was reported that the balloon catheter encountered difficulty during advancement and removal over the guide wire.Analysis of the returned device confirmed the outer diameter to be within specification.It was also noted that the proximal end of the polymer coating was torn.This indicates interaction between the guide wire and catheter.It is possible that the polymer became damaged during use and contributed to the reported difficulties during advancement/removal.Additionally, it was reported and confirmed that the teflon coating on the proximal end had peeled.This type of damage is typical of handling.This is supported by the bends located on the proximal end, which also indicate handling.There is no indication of a product quality issue with respect to manufacture, design, or labeling.D09, h3: device available for evaluation updated to yes.H6: type of investigation code 4114 removed.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 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: 18356611
• Report Number: 2024168-2023-14219
• Device Sequence Number: 6794549
• Product Code: DQX
• UDI-Device Identifier: 08717648118777
• UDI-Public: (01)08717648118777(17)240831(10)2092071
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K072460
• 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,Followup
• Report Date (Section B): 06/17/2024

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: 08/31/2024
• Device Catalogue Number: 1009666J
• Device Lot Number: 2092071
• 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: 12/07/2023
• Supplement Date Received by Manufacturer: 01/22/2024; 03/05/2024; 06/04/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 02/09/2024; 03/07/2024; 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 75 KG