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

Catalog Number 1001309S

Device Problems Detachment Of Device Component (1104); Difficult To Position (1467); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that an iron man guidewire failed to cross the distal right coronary artery (rca), heavily calcified lesion.A second attempt was unsuccessfully made using a buddy wire and guideliner.The iron man was removed without issue.The same iron man guidewire was re-advanced a 3rd time with a buddy wire and guideliner.Additionally, a balloon catheter was advanced on the wire, but the balloon catheter felt different, with no noted resistance.Fluoroscopy images were viewed and it was then noted that the iron man guidewire tip had separated inside the guideliner.All was removed from the patients anatomy.Nothing was left inside the patients anatomy.There were no adverse patient effects and there was no clinically significant delay in procedure.There was no additional information provided.

Manufacturer Narrative

Internal file number - (b)(4).Evaluation summary: visual and dimensional inspections were performed on the returned device.The separation was confirmed.The failure to advance could not be replicated in a testing environment as it was based on operational circumstances.The difficult to position could not 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 identified no other similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure and 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 IRON MAN 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: 6281193
• MDR Text Key: 66127200
• Report Number: 2024168-2017-00695
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060449
• 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: 02/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 1001309S
• Device Lot Number: 6090761
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• 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 Age: 54 YR
• Patient Weight: 125