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

Catalog Number 2078175

Device Problems Detachment Of Device Component (1104); Improper or Incorrect Procedure or Method (2017); Physical Resistance (2578); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).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 during the procedure to treat a target lesion in the distal tibialis artery, the ht command guide wire was advanced with difficulty to the target site.The guide wire tip prolapsed and formed a small loop in the patient anatomy.A 1.5 x 80 mm armada 14 dilatation catheter had been advanced over the guide wire.Some resistance was noted during advancement of the armada 14; however, the dilatation catheter was able to advance to the target lesion and the balloon was inflated.The armada 14 was removed without difficulty; however, the tip of the guide wire separated at the portion that was prolapsed.It was suspected that the balloon may have had an impact on the guide wire tip detachment.A snare device was advanced to remove the separated tip and caused a perforation.Additional balloon inflations were performed to treat the perforation and the guide wire tip was removed from the anatomy.No additional information was provided.

Manufacturer Narrative

(b)(4).Visual and dimensional inspections were performed on the returned device.The reported separation was confirmed although the reported physical resistance and device operating differently than expected could not be replicated in a testing environment as it was based on operational circumstances of the procedure.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents from this lot.The ht command instructions for use (ifu) instructs not to allow the guide wire tip to remain in a prolapsed condition.The investigation determined the reported separation to be related to a deviation to the ifu and the reported physical resistance and device operating differently than expected as well as the treatments to be related to operational circumstances of the procedure.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: 6911255
• MDR Text Key: 88043813
• Report Number: 2024168-2017-07946
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K103101
• 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: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 2078175
• Device Lot Number: 7053071
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/02/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2017
• Initial Date FDA Received: 10/03/2017
• Supplement Dates Manufacturer Received: 10/20/2017
• Supplement Dates FDA Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2017
• 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: DIL CATH: ARMADA 14 1.5X80
• Patient Outcome(s): Required Intervention