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

Model Number	1009666J
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat an unspecified lesion in the first diagonal (1st) artery.A 2.75x15mm nc trek balloon dilatation catheter (bdc) was advanced for post-dilatation, however the bdc met resistance with the ht bmw universal ii guide wire (gw) and became stuck on the guide wire preventing it from reaching the target lesion.The bdc was inflated one time, close to the target lesion, however the balloon did not deflate.Damage was noted to the shaft of the bdc which was preventing the balloon from deflating.The inflated balloon and the guide wire were removed from the anatomy.A 190cm j bmw universal ii gw was then advanced to the target lesion with resistance met from the anatomy and an abbott balloon was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Returned device analysis found that the teflon coating was scratched.No additional information was provided.
Additional Manufacturer Narrative
The additional two devices referenced are filed under separate medwatch report numbers.The device was returned for analysis.The reported difficult to advance was unable 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 did not indicate a lot specific quality issue.He investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the reported/noted multiple damages to the balloon dilatation catheter (see (b)(4)) resulted in the reported difficult to advance.The noted scraped teflon coating is most likely due to the torque device being tightened against the guidewire.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Additional Manufacturer Narrative
H10: reference (b)(4).Was filed under another mfr number.No other reports were filed.B1: filed in error.Not reportable.H10: reported 2 additional reports were filed, but only one was deemed reportable and was filed.
Event or Problem Description
Subsequent to the previous report, it was noted that this report was filed in error.This event was deemed as not reportable.

• 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: 15677706
• Report Number: 2024168-2022-11076
• Device Sequence Number: 2303510
• Product Code: DQX
• UDI-Device Identifier: 08717648118777
• UDI-Public: 08717648118777
• 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
• Report Date (Section B): 11/01/2022

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: 01/31/2024
• Device Model Number: 1009666J
• Device Catalogue Number: 1009666J
• Device Lot Number: 2020971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2022
• Supplement Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2022
• 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