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

Model Number	1001782J-HC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during unpacking of a balance middleweight hydro guide wire, it was noted to be uncoiled at the tip.The device was not used and there was no patient involvement.A new 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 evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
A visual inspection was performed on the returned guide wire and the reported break/separation was 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 similar incidents and/or complaints reported from this lot.Possible factor that may contribute to guide wire breaks/separations can be affected by numerous factors including, but not limited to, mishandling during manufacturing, guide wire damage during unpacking, guide wire damage during removal from dispenser coil or preparation, guide wire re-insertions, handing/manipulation, tensile or torsional loads beyond its design limits, entanglement with other devices or anatomical conditions.The investigation was unable to determine a conclusive cause for the reported tip/shaping ribbon break/separation.The noted coil damages were likely the result of the noted shaping ribbon and coil separations.The core kink and teflon damages likely occurred during packing for return analysis.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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
• 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: 13392629
• Report Number: 2024168-2022-00989
• Device Sequence Number: 4382793
• Product Code: DQX
• UDI-Device Identifier: 08717648026010
• UDI-Public: 08717648026010
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2022

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: 08/31/2023
• Device Model Number: 1001782J-HC
• Device Catalogue Number: 1001782J-HC
• Device Lot Number: 1090971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/14/2022
• Supplement Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2021
• 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