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

Catalog Number 1044588

Device Problems Peeled/Delaminated (1454); Difficult To Position (1467); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2016

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 additional relevant information.

Event Description

It was reported that an advance guide wire was positioned without issue.A non-abbott balloon catheter was attempted to advance over the guide wire; however, resistance was noted between the guide wire and balloon catheter, so removal of the balloon catheter was attempted, but the devices were stuck.The balloon catheter was removed with force and a blue colored material was observed stuck over the proximal guide wire.The material appeared to be peeling from the wire coating, but may have been material from the balloon catheter.The guide wire was removed from the anatomy.There were no adverse patient effects and there was clinically significant delay.There was no additional information provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis with a non-abbott balloon catheter on the proximal end.The non-abbott catheter balloon was separated from the tip and seal and not returned.Visual, dimensional and functional inspections were performed on the returned device.The difficult to position and remove the balloon catheter and peeling were not confirmed.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.The investigation was unable to determine a conclusive cause for the reported difficult to position and peeling; however, the difficulty removing the balloon catheter appears to be related to circumstances of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: HI-TORQUE ADVANCE 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: 6061750
• MDR Text Key: 58768355
• Report Number: 2024168-2016-07345
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K060449
• 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: 11/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 1044588
• Device Lot Number: 6070161
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/19/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2016
• Initial Date FDA Received: 10/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• 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
• Treatment: DILATATION CATHETER: 2.5-15MM KAMUI