MAUDE Adverse Event Report: AV-TEMECULA-CT RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER

Catalog Number 1008191-40

Device Problems Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.Based on the reported information, there is no indication of a product quality issue with respect to manufacture, design, or labeling.The investigation determined that the reported difficulties appear to be due to case circumstances.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 similar incidents from this lot.Although it was reported that the inflation lumen was inadvertently flushed instead of the guide wire lumen during preparation, the error does not appear to have contributed to the reported difficulties.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was performed to treat a popliteal lesion with heavy calcification.The 4.5 mm x 40 mm x 135 cm rx viatrac was prepped outside the body; however, the technician filled the inflation lumen thinking it was the guide wire lumen.No resistance was noted during removal of the protective sheath.There was resistance during advancement to the target lesion and due to the patient anatomy the balloon tore and a segment of the catheter with the balloon on it partially separated from the catheter and they could not get to the lesion.There was also resistance during retraction of the balloon catheter; however, the catheter with balloon on it was removed from the patient over the guide wire without losing access.The procedure was completed with balloon dilatation and a stent.There was no reported clinically significant delay in the procedure.There was no adverse patient effect.No additional information was provided.

• Brand Name: RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• 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: 5522014
• MDR Text Key: 41124183
• Report Number: 2024168-2016-01869
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102705
• 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
• Report Date: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: 1008191-40
• Device Lot Number: 5021161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2015
• 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
• Patient Age: 65 YR
• Patient Weight: 66