MAUDE Adverse Event Report: ABBOTT VASCULAR ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATI

Model Number	1001782-HC
Medical Device Problem Codes	Material Separation (1562); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the right posterior tibial artery.Vessel access was via the left common femoral artery.An angled non-abbott guide wire was advanced; however, the device was unable to cross.Therefore, retrograde access was made via the pedal artery.The balance middleweight (bmw) guide wire was advanced; however, resistance was noted due to the patient anatomy.The guide wire was noted to separate into two segments, but was able to be easily removed from the anatomy.No difficulty was noted during removal.There was no adverse patient effect or clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned guide wire and the reported core separation was confirmed.The reported failure to advance was unable to be replicated in a testing environment as it was based on operational circumstances.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.There was no damage noted to the guide wire during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.The investigation determined the reported failure to advance, core separation, treatment and noted damages appear to be related to operational circumstances of the procedure.Based on the reported information, the guide wire encountered resistance with the anatomy resulting in the failure to advance.Manipulation against resistance like resulted in the core separation and tip damages, causing the tip to kink and separate while in the guiding catheter.Additionally, the treatment appears to be related to the operational context of the procedure as a dilatation balloon catheter was inflated in the guide catheter and the guide wire was removed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6: health effect - impact code: code 2199 removed.
Event or Problem Description
User facility medwatch report received that states: "peripheral intervention of cto of rt sfa.Unable to cross lesion using antegrade approach therefore, cto was attempted to be crossed from retrograde pedal artery access.The abbott bmw.014/300 wire was used and was attempted to be snared from antegrade access but the wire was.No adverse affects noted and procedure was successfully completed." subsequent to the initial mdr report, additional information was provided.When the bmw guide wire separated, a 2.0 mm dilatation catheter balloon was inflated in the guide catheter and the guide wire was able to be removed.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.

• Brand Name: ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATI
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12282337
• Report Number: 2024168-2021-06863
• Device Sequence Number: 17104280
• Product Code: DQX
• UDI-Device Identifier: 08717648025990
• UDI-Public: 08717648025990
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2021

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: 07/31/2022
• Device Model Number: 1001782-HC
• Device Catalogue Number: 1001782-HC
• Device Lot Number: 0081072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 08/05/2021
• Supplement Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 84