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

Model Number 1001780-HC

Device Problems Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)

Patient Problems Angina (1710); Low Blood Pressure/ Hypotension (1914); Occlusion (1984)

Event Date 11/05/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat a de novo lesion in the heavily calcified, mildly tortuous left anterior descending coronary artery.A balance middleweight hydro guide wire failed to cross due to the anatomy.Then, the guide wire was unable to be removed due to resistance with the anatomy, and force was applied.The tip of the guide wire separated, so a snare was attempted to retrieve the separated portion but failed.The right circumflex coronary artery became occluded and the patient developed hypotension, angina, and heart pain.The separated portion was surgically removed, and bypass surgery was performed.There was a clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual and dimensional analysis was performed on the returned device.The separation was confirmed.The failure to advance and difficult to remove could not be confirmed as it was reported to have occurred with the anatomy.The lot history record (lhr) for this product could not be reviewed and a similar complaint query could not be performed because the product was not returned for evaluation and the lot number was not reported.The reported patient effect of occlusion is listed in the hi-torque wire instruction for use as a known potential patient effect associated with the use of a wire in coronary or peripheral arteries and / or biliary tree.It should be noted that ifu, ht guide wires instructions for use states: ¿carefully observe the instructions under ¿do not¿ and ¿do¿ below.Failure to do so may result in vessel trauma, guide wire damage, guide wire tip separation, or stent damage.If resistance is observed at any time, determine the cause under fluoroscopy and take remedial action as needed.Do not: push, auger, withdraw or torque a guide wire that meets resistance.Torque a guide wire if the tip becomes entrapped within the vasculature.In this case the reported event stated there was resistance was felt and force was applied, which likely caused or contribute to the reported material separation.Based on the case information, the cause of the material separation, failure to advance, and difficult to remove are related to the circumstances of the procedure.In this case, it is likely the wire was damaged during the failed attempt to cross the heavily calcified artery, then separated during the attempted removal with force against resistance.The reported patient effects of occlusion, hypotension, angina, and reported additional treatment, surgical procedure, removal of foreign object and prolonged hospitalization appear to be related to case circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
• Type of Device: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10906675
• MDR Text Key: 218743750
• Report Number: 2024168-2020-09937
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08717648025969
• UDI-Public: 08717648025969
• Combination Product (y/n): N
• PMA/PMN Number: K021228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/19/2021

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
• Device Operator: Health Professional
• Device Model Number: 1001780-HC
• Device Catalogue Number: 1001780-HC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Initial Date Manufacturer Received: 11/06/2020
• Initial Date FDA Received: 11/25/2020
• Supplement Dates Manufacturer Received: 12/29/2020
• Supplement Dates FDA Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability