MAUDE Adverse Event Report: AV-TEMECULA-CT HT COMMAND; GUIDE WIRE

Catalog Number 2078175

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/22/2016

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.The other ht command es guide wire referenced in describe event or problem is being filed under a separate manufacturing report number.

Event Description

It was reported that during the procedure to treat a non-calcified lesion in the non-tortuous posterior tibial artery, a hi-torque (ht) command es guide wire was advanced via common femoral artery access to the lesion without issue.When attempting to advance a non-abbott balloon catheter over the ht command guide wire, the balloon catheter became stuck (unable to advance or retract) on the ht command guide wire prior to entering patient anatomy.Both the balloon catheter and guide wire were withdrawn as a single unit.Another same size and lot ht command es guide wire was advanced to the lesion without issue.Another non-abbott balloon catheter was advanced over the new ht command es guide wire and to the lesion without issue; the balloon was inflated then deflated without issue.However, when attempting to re-position the balloon catheter over the ht command es wire, this balloon catheter became stuck (unable to be advanced or retracted) on this guide wire.Both devices were withdrawn as a single unit.An unspecified coronary guide wire was used successfully with another non-abbott balloon catheter to complete dilatation.There were no adverse patient effects and no occurrence of a clinically significant delay.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: visual, dimensional and functional inspections were performed on the returned device.The reported difficult to position and remove was confirmed.The investigation was unable to determine a conclusive cause for the reported difficulties.Sterile/unopened ht-command 300cm guide wires were returned to abbott vascular (same part and lot numbers) for further analysis and the analysis was unable to confirm 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 did not indicate a lot specific quality issue.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.

• Brand Name: HT COMMAND
• 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: 5953051
• MDR Text Key: 55148643
• Report Number: 2024168-2016-06111
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103101
• 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,Followup
• Report Date: 09/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 2078175
• Device Lot Number: 6061371
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• 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: EV3