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

Catalog Number 1010485-H

Device Problems Difficult To Position (1467); Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2016

Event Type  malfunction  

Manufacturer Narrative

(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 relevant information.

Event Description

It was reported that the procedure was to treat a lesion in the lower limb.After placement of the.014" hi-torque pilot guide wire (gw), the 2.0 x 120 mm armada balloon catheter was inserted, but could not be advanced on the gw so it was removed.A 2.0 x 80 mm armada was then attempted to be advanced, but it also could not advance on the gw and was removed.The physician had noted prior to use that the pilot gw felt stiffer than usual.The gw was exchanged for a new.014" hi-torque pilot gw and the 2.0 x 120 mm armada was advanced and used successfully in the procedure.The nurse noted that the 1st gw seemed bigger than the 2nd gw.It was more like a.018" gw and not even like a pilot gw; she thought it seemed like a non-abbott gw.The nurse confirmed that the gw package was sealed until use in the procedure.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.Visual, dimensional, and functional inspections were performed on the returned device.The difficult to position with the balloon catheter and mislabeling 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.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The investigation was unable to determine a conclusive cause for the reported difficulties.

• Brand Name: HI-TORQUE PILOT 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): 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: 5938155
• MDR Text Key: 54648864
• Report Number: 2024168-2016-05949
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 09/30/2016

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: 04/30/2018
• Device Catalogue Number: 1010485-H
• Device Lot Number: 6050971
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/07/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2016
• Initial Date FDA Received: 09/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2016
• 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: ARMADA 2.0X80MM, 2.0X120MM