MAUDE Adverse Event Report: AV-TEMECULA-CT HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE

Catalog Number 1011880J

Device Problems Detachment Of Device Component (1104); Failure to Advance (2524); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2016

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 not returned 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 incidents reported from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.

Event Description

It was reported the procedure was to treat a lesion with moderate tortuosity and heavily calcification in the distal right coronary artery (rca).The balance middleweight (bmw) elite guide wire was advanced to the proximal circumflex artery with no issues and an unspecified stent was implanted.The guide wire was moved to the rca distal lesion into the posterior left ventricular (plv) branch.An unspecified stent was implanted successfully into the plv from the distal rca.After the procedure, the physician decided to try to re-wire through the mid stent to open the side cell of the stent in the posterior descending artery (pda); however, the guide wire did not cross through the existing stent implant and curled up in the proximal stent.After slight attempts to straighten the guide wire by pulling back the guide wire, it was decided to end the procedure.When the guide wire was withdrawn from the patient anatomy, it was noted that the distal end of the guide wire was detached and partially in the aorta.Attempts were made to snare the separated guide wire piece, but the guide wire dislodged and traveled to the subclavian and partially in the aorta.More attempts were made to snare the separated piece, but the separated guide wire piece traveled down to the iliac bifurcation.After a few more attempts, the separated piece was captured with a snare and withdrawn without any further complication.The patient recovered with no further problems.There was no adverse patient sequela.There was a significant delay in the procedure; however, it was not reported to be clinically significant.No additional information was provided.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE
• Type of Device: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; 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: 5831523
• MDR Text Key: 50714097
• Report Number: 2024168-2016-05017
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103101
• 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
• Report Date: 07/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 1011880J
• Device Lot Number: 6022661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2016
• 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: 62 YR
• Patient Weight: 107