MAUDE Adverse Event Report: AV-TEMECULA-CT ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

Catalog Number 1000462H

Device Problems Detachment Of Device Component (1104); Difficult To Position (1467); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/19/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was to place a non-abbott embolic protection device (epd) in a non-calcified, very tortuous carotid artery for embolic protection during a transcatheter aortic valve replacement (tavr) procedure.A 014 balance heavyweight (bhw) hydro 190cm guide wire was advanced via radial access to the carotid artery without difficulty.An attempt was then made to advance the epd over the bhw guide wire, but the epd became stuck on the guide wire.The epd was pushed and pulled over the bhw in attempts to facilitate advancement of the epd.During a final attempt to advance the epd, the distal end of the bmw separated in the brachial artery.The tavr procedure was completed and then the separated guide wire piece was retrieved from the brachial artery via surgical intervention.While this issue caused a delay (due to the need for surgery), the delay did not result in a health impact.There were no adverse patient sequelae.No additional information was provided.

Manufacturer Narrative

(b)(4).Visual and dimensional inspection was performed on the returned device.The reported separation was confirmed although the reported difficult to position and difficult to remove was unable to be confirmed due to the condition of the device.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 from this lot.It should be noted that this device was used in the carotid artery; however, the device instruction for use 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).The investigation was unable to determine a conclusive cause for the reported difficulties.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 HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
• Type of Device: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): BARCELONETA, PUERTO RICO REG# 3005737652; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6802675
• MDR Text Key: 82980887
• Report Number: 2024168-2017-06775
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013833
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 1000462H
• Device Lot Number: 7050372
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/02/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR