MAUDE Adverse Event Report: AV-TEMECULA-CT HI-TORQUE BALANCE GUIDE WIRE WITH MICROGLIDE COATING

Catalog Number 28000S

Device Problems Difficult To Position (1467); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported the balance guide wire met resistance with associative devices during advancement and removal of the devices.There was no adverse patient effect.No additional information was provided.

Manufacturer Narrative

(b)(4).The used guide wire was not returned and may have helped to determine the root cause of the resistance during the procedure.Sterile samples from the same part and lot number were returned and tested, with no deficiencies found related to design, manufacturing or labeling.The lot history record was reviewed and identified no manufacturing nonconformities that were related to the failure mode.A review of the complaint handling database found 2 similar incidents from this lot.These devices will continue to be monitored.

• Brand Name: HI-TORQUE BALANCE GUIDE WIRE WITH MICROGLIDE 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: 5564674
• MDR Text Key: 42438019
• Report Number: 2024168-2016-02303
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K013833
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 28000S
• Device Lot Number: 5102671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2015
• 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