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	Off-Label Use (1494); Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to abbott vascular 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 identified no other similar incidents reported from this lot.It should be noted that instructions for use guide wire hi-torque guide wires ce, fda (ppl2121799, revision a, intended use section states: all hi-torque guide wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (ptca) and percutaneous transluminal angioplasty (pta).In this case, the reported ifu violation of the guide wire used during a shockwave procedure does not appear to have caused or contributed to the reported difficulty to remove or separation.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 difficulty to remove and tip separation appear to be related to operational circumstances of the procedure.Based on the reported information, it is likely that during advancement of the two non-abbott devices, they became tangled and stuck on the guide wire causing damage to the guide wire and the difficulty to remove.Manipulation during retraction likely resulted in the reported separation.Additionally, the treatment appears to be related to the operational context of the procedure as the separated portions of the guide wires were retrieved using a snare device.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that during a shockwave procedure in the right common femoral artery (cfa), two non-abbott devices became stuck with each other while advancing over a 3cm 014 balanced middle weight (bmw) hydro guide wire (gw).The devices were removed against resistance, but the bmw guide wire remained in place and a new, non-abbott device was advanced over the wire.During removal of the non-abbott device, approximately 15cm of the distal bmw guide wire separated and remained in the anatomy.A snare was used to successfully remove the separated portion of the bmw.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.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: 11406631
• Report Number: 2024168-2021-01690
• Device Sequence Number: 11606162
• Product Code: DQX
• UDI-Device Identifier: 08717648025990
• UDI-Public: 08717648025990
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/03/2021

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: 05/31/2022
• Device Model Number: 1001782-HC
• Device Catalogue Number: 1001782-HC
• Device Lot Number: 0060171
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 03/03/2021
• 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