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

Catalog Number 1001780JS-HC

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported the patient presented with severe coronary artery disease in 5 vessels and coded at the hospital.The patient was not a surgical candidate; therefore, percutaneous coronary intervention was performed.The vessels were heavily calcified with moderate tortuosity.First, the left anterior descending artery was treated successfully without patient consequences.The patient was put on a ventricular assist device to continue treating the other vessels and the patient continued to be stable.The balance middleweight (bmw) guide wire was advanced down the distal circumflex to the obtuse marginal artery, but angiography revealed that approximately 30 mm of the guide wire tip had prolapsed.The guide wire tip was looped where the vessel was 99% stenosed, so when the physician attempted to re-position the guide wire, the guide wire tip separated.A snare device was used to remove the separate tip successfully.The vessel was re-wired with a non-abbott guide wire successfully; however, a perforation occurred.The perforation was sealed with ballooning and stent placement successfully.Echocardiogram noted no tamponade and no leaks.The patient continued to be in stable condition when he was removed from the cath lab; however, the patient died the next morning.The reported cause of death was due to severe multi-vessel coronary artery disease and very poor health.Reportedly, the bmw did not cause or contribute to the perforation as the guide wire had been removed before the perforation occurred and occurred 25 mm distal to where the bmw guide wire had been placed.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was initially reported as returning; however, the device was not returned.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 similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that as the guide wire was advanced interaction with the heavily calcified, moderately torturous and 99% stenosed anatomy resulted in the guide wire to become prolapsed resulting in the reported device operates differently.Manipulation to re-position the guide wire and/or interaction with the 99% stenosed anatomy resulted in the reported tip detachment.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: ACS HI-TORQUE BALANCE MIDDLEWEIGHT 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: 7136224
• MDR Text Key: 95447696
• Report Number: 2024168-2017-10009
• 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: 01/22/2018

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: 07/31/2019
• Device Catalogue Number: 1001780JS-HC
• Device Lot Number: 7081172
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 12/20/2017
• Supplement Dates Manufacturer Received: 01/18/2018
• Supplement Dates FDA Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2017
• 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: 84 YR
• Patient Weight: 77