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

Catalog Number 1008197-20

Device Problems Difficult to Remove (1528); Stretched (1601); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2018

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 has not yet been received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a non-tortuous, mildly calcified iliac artery.A 6.0x20mm viatrac balloon dilatation catheter failed to advance on a 0.014 guide wire (gw) as it met resistance with the gw and got stuck.The device was removed and it was noted that the tip was damaged.No patient effects.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Device codes: 2017 labeled.Internal file number - (b)(4).Corrections: device status changed from returning to not returned.Device code 2017-excessive force.The device was not returned for analysis.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 of the reported lot revealed no other incidents.It should be noted that the viatrac plus instruction for use states: if resistance is met during manipulation, determine the cause of the resistance before proceeding.The investigation was unable to determine a cause for the reported difficulties.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Correction to case details: the physician applied excessive force to try to advance the balloon over the wire.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
• MDR Report Key: 8302281
• MDR Text Key: 134910532
• Report Number: 2024168-2019-00802
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K102705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2019

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: 12/31/2019
• Device Catalogue Number: 1008197-20
• Device Lot Number: 8011661
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/11/2019
• Initial Date FDA Received: 02/04/2019
• Supplement Dates Manufacturer Received: 02/28/2019
• Supplement Dates FDA Received: 03/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 23 YR