MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE WHISPER MS GUIDE WIRE

Model Number	1005357HJ
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	11/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned to abbott vascular for analysis.A review of the electronic lot history record (elhr), corrective action tracking system for the web (catsweb) database review and similar incident query for this product was not performed since the lot number was not reported.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.It should be noted that the electronic instructions for use guide wire hi-torque guide wires ce fda (ifu), 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 use extreme caution when moving a guide wire through a non-endothelialized stent, or through stent struts into a bifurcated vessel.Use of this technique carries additional patient risks, including the risk that the wire may become caught on the stent strut.The reported ifu violation appears to have been caused or attributed to user error.The technique and/or manipulation of the guide caused the reported jailing and/or entrapment of the guide wire tip.Further manipulation to free the guide wire ultimately led to the tip separation the investigation determined the reported entrapment of the device, tip separation, and additional therapy non-surgical treatment of removal of the separated tip using a snare device appear to be related to user error.In this case, the technique and/or manipulation of the guide caused the reported jailing and/or entrapment of the guide wire tip.Further manipulation to free the guide wire ultimately led to the tip separation which was ultimately removed using a snare device.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
User facility medwatch report (b)(4) received stating: patient to cath lab for heart cath with percutaneous coronary intervention of the left anterior descending coronary artery.Stent was successfully placed in left descending coronary artery, but then dissection was noted.Multiple stents were deployed, and then dissection noted at main coronary artery, and then left circumflex coronary artery.After stents deployed, patient decompensated and cpr was started.Impella was placed, and balloon inflations into circumflex artery were performed.They performed a couple of balloon inflations with the 2 x 15 mm emerge balloon in the left circumflex.This was done over a whisper wire, which was advanced into the left circumflex.At this time, the whisper wire tip became entangled in the left main stent and the end of it sheared off.It was retrieved with en snare device.They were able to restore flow in the left circumflex with balloon inflations.The following additional information was received: the patient decompensated prior to wiring the left circumflex artery (lcx), resulting in prolonged hospitalization.The slow flow in the lcx was before wiring with the whisper.No additional information was provided.
Additional Manufacturer Narrative
H6: investigation findings/result code: 3252 - removed.Investigation conclusion codes: 4307, 4311 - removed.

• Brand Name: HI-TORQUE WHISPER MS GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11521630
• Report Number: 2024168-2021-02169
• Device Sequence Number: 14603019
• Product Code: DQX
• UDI-Device Identifier: 08717648037818
• UDI-Public: 08717648037818
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K101116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2021

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
• Operator of Device: Health Professional
• Device Model Number: 1005357HJ
• Device Catalogue Number: 1005357HJ
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 03/19/2021
• 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: 72 YR
• Patient Weight: 93