MAUDE Adverse Event Report: AV-TEMECULA-CT ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE; GUIDE WIRES

Catalog Number 1001780S

Device Problems Break (1069); Difficult to Remove (1528); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the patient presented with a st elevated myocardial infarction and the procedure was performed to treat a calcified lesion in the left anterior descending coronary artery.A balance middle weight (bmw) guide wire was advanced with no resistance; however, on removal of the guide wire resistance with the anatomy was met and the tip unraveled.The guide wire and an unspecified balloon dilatation catheter were therefore removed from the anatomy as a single unit.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The reported break and the reported stretched were able to be confirmed.The reported difficult to remove was unable to be replicated in a testing environment as it was based on operational circumstances.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 from this lot.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 as it is likely that during removal resistance was met with the calcified lesion resulting in the reported difficulty to remove.Manipulation of the device resulted in the reported stretched coils, the noted bends (core, shaping ribbon) and ultimately resulted in the reported break/noted core separation.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
• Type of Device: GUIDE WIRES
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8185099
• MDR Text Key: 131378759
• Report Number: 2024168-2018-09930
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• PMA/PMN Number: K101116
• 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: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• 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: 1001780S
• Device Lot Number: 8091971
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/13/2018
• Date Manufacturer Received: 01/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 98