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

Catalog Number 1008197-20

Device Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2018

Event Type  malfunction  

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 completed. A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a mildly tortuous and moderately calcified right carotid artery in the carotid siphon area. A 6. 0 x 20 mm viatrac plus peripheral dilatation catheter was used; however, a kink in the shaft was noted during unpacking. Therefore, the device failed to cross the lesion and was replaced with a 4. 0 x 20 mm trek balloon dilatation catheter to successfully complete the procedure. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided. Returned device analysis revealed that there was a white foreign material on the skive/bayonet of the device. Follow-up was performed regarding the white foreign material; however, the hospital stated the foreign material was not noticed.

Manufacturer Narrative

Internal file number - (b)(4). Evaluation summary: visual, dimensional and additional ftir testing was performed on the returned device. The reported failure to advance was not confirmed as it was based on case circumstances. The kink was 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 similar incidents from this lot. It should be noted that the viatrac plus instruction for use (ifu) states: do not use, or attempt to straighten, a catheter if the shaft has become bent or kinked as this may result in the shaft breaking. Instead, prepare a new catheter. Additionally, it was reported that the viatrac plus was being used to treat a mildly tortuous and moderately calcified right carotid artery in the carotid siphon area. The indications for use section of the ifu indicates: the viatrac 14 plus peripheral dilatation catheter is intended to dilate stenosis in the peripheral arteries (iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal arteries). Or for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The investigation determined the reported difficulties appear to be user related. Although the reported kink was not confirmed on the returned unit, a kinked shaft would cause difficulty advancing; therefore, using a damaged device would contribute to the difficulties encountered. 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: 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: 8011672
• MDR Text Key: 125277470
• Report Number: 2024168-2018-08224
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K102705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri

Reporter Occupation

• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/03/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 1008197-20
• Device Lot Number: 6071961
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/03/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/26/2018
• 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