MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 018 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number U8150322

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 02/08/2018

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that the inner packaging label referenced a 2mm size balloon and the outer packaging label referenced a 3mm size balloon.There was no patient contact.

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: although the sample was not returned for evaluation, two electronic photos were provided for review.The investigation is inconclusive for the reported packaging issue, as the photo review could not confirm that the 2mm labeled device was packaged within the 3mm labeled outer box.The reported 2mm device lot was manufactured and shipped from the manufacturing site 3 months prior to the 3mm device packaging.Therefore, it is highly unlikely that the reported issue is manufacturing related.It is unknown if a mix-up occurred at the user facility.A definitive root cause for the reported issue could not be determined based on the available information.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.

Event Description

It was reported that the inner packaging label referenced a 2mm size balloon and the outer packaging label referenced a 3mm size balloon.There was no patient contact.

• Brand Name: ULTRAVERSE 018 PTA DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 7321104
• MDR Text Key: 101891773
• Report Number: 2020394-2018-00204
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741064913
• UDI-Public: (01)00801741064913
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121856
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: U8150322
• Device Catalogue Number: U8150322
• Device Lot Number: CMBV0077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2017
• 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