MAUDE Adverse Event Report: ABBOTT VASCULAR RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER; PEREIPHERAL DILATATION CATHETER

Model Number	1008189-30
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.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 identified one similar complaint from this lot for this potential product quality issue therefore it is associated to the exception.The complaint investigation determined that the label on the complaint device was not created by abbott west distribution center (awdc) or abbott vascular netherlands (avn).The label font, format and content do not match the approved label, aal2107322-01.Therefore, there is no product quality issue with respect to the design, manufacture or labeling of the device.The other four rx viatrac plus devices referenced are filed under separate medwatch report numbers.
Event or Problem Description
It was reported that during device preparation, the outer package labeling did not match the inner package product of 5 viatrac plus balloon dilatation catheters.The outer packages were labeled as viatrac plus 4x30mm 135cm but the devices in the packages were 6x30mm 135 cm.The devices were not used.There was no patient involvement and no clinically significant delay in procedure.No additional information was provided regarding this issue.

• Brand Name: RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER
• Common Device Name: PEREIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11016762
• Report Number: 2024168-2020-10578
• Device Sequence Number: 16361202
• Product Code: LIT
• UDI-Device Identifier: 08717648056833
• UDI-Public: 08717648056833
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K072798
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/15/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 1008189-30
• Device Catalogue Number: 1008189-30
• Device Lot Number: 0022561
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1