MAUDE Adverse Event Report: AV-TEMECULA-CT HI-TORQUE WHISPER LS GUIDE WIRE; GUIDE WIRES

Catalog Number 1005351H

Device Problems Detachment Of Device Component (1104); Kinked (1339); Device Operates Differently Than Expected (2913)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 01/28/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 during a procedure of the tight, second marginal branch of the circumflex (cx) artery, after balloon pre-dilatation and several devices failed to cross the lesion, a different balloon catheter was attempted to be advanced when the whisper guide wire slipped into the left anterior descending (lad) artery.Using angiography it was noted that the distal tip of the whisper guide wire had separated and was in the mid cx artery; reportedly, no force or pulling was done to the guide wire.The physician suspected the sharp angle from the cx into the marginal may have created a kink which may have caused/contributed to the separation.The proximal portion of the guide wire was removed from the anatomy and the separated fragment was fixed to the vessel wall using an unspecified drug eluting stent but not at the target lesion.The marginal was later treated with an unspecified device after positioning a different whisper ls guide wire in the vessel.There was no reported adverse patient sequela.There was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned.The reported separation was confirmed although the reported kink was not confirmed.Furthermore, the device operating differently could not be replicated in a testing environment as it was based on operational circumstances.Based on the visual inspection of the returned device, there is no indication of a product quality issue with respect to manufacture, design or labeling.The investigation determined the reported separation was based on the patients anatomical conditions.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 similar incidents from this lot.Based on the information reviewed, there is no indication of a product quality issue with the respect to manufacturing, design or labeling.

• Brand Name: HI-TORQUE WHISPER LS GUIDE WIRE
• Type of Device: GUIDE WIRES
• 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: 5452946
• MDR Text Key: 38747996
• Report Number: 2024168-2016-01059
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K101116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/25/2016

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 Expiration Date: 09/30/2017
• Device Catalogue Number: 1005351H
• Device Lot Number: 5100571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2016
• Initial Date FDA Received: 02/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• 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