MAUDE Adverse Event Report: AV-TEMECULA-CT ACS HI-TORQUE ALLSTAR GUIDE WIRE

Catalog Number 1001741S

Device Problems Difficult to Remove (1528); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2018

Event Type  malfunction  

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 evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat the right coronary artery that did not have any tortuosity or calcification.During a procedure while removing the dragonfly optical imaging catheter over the allstar guide wire, resistance was met and the devices could not be removed separately.The catheter and guide wire were removed together.Outside the anatomy it was noted that the guide wire coils were mangled.There were no adverse patient effects and no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Evaluation summary: the device was returned for analysis.The reported material twisted was unable to be confirmed; however, there were noted core damages (bent, prolapsed).The reported difficult to remove was unable to be replicated in a testing environment due to the condition of the returned 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 did not indicate a lot specific quality issue.As there was no damage noted to the guide wire during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure.Manipulation of the device resulted in the reported material twisted/noted bent and prolapsed core damages.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: ACS HI-TORQUE ALLSTAR GUIDE WIRE
• Type of Device: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8180436
• MDR Text Key: 130976166
• Report Number: 2024168-2018-09870
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• PMA/PMN Number: K060449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 1001741S
• Device Lot Number: 8091061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Date Manufacturer Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OTHER: DRAGONFLY OPTICAL IMAGING CATHETER
• Patient Age: 78 YR
• Patient Weight: 87