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

Catalog Number 1001782JS

Device Problems Defective Device (2588); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/29/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It is indicated that the device is not returning; therefore, a failure analysis of the complaint device could not be completed.The investigation was unable to determine a conclusive cause for the reported difficulties.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.Based on the information reviewed, there is no indication of a product quality issue with the respect to manufacturing, design or labeling.The other hi-torque balance middleweight guide wire referenced is filed under a separate medwatch mfr number.

Event Description

It was reported that normally the j tip balance middle-weight (bmw) guide wire has a 45 degree bend, but the two bmws used had an almost 90 degree bend.The bmw prolapsed during advancement which resulted in trouble steering, but the two guide wires were successfully used in the procedure.There were no adverse patient effects.No additional information was provided.

• 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
• 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: 5503022
• MDR Text Key: 40586583
• Report Number: 2024168-2016-01626
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101116
• 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: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: 1001782JS
• Device Lot Number: 5083171
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2015
• 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: 68 YR
• Patient Weight: 90