MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. UNK CONQUEST PTA BALLOON DILATATION CATHETER; DQY

Catalog Number UNK CONQUEST

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that the pta balloon size differed from the what was indicating on the labeling.There was no patient injury reported.

Manufacturer Narrative

A further clinical review was performed and identified this event to be mdr reportable pursuant to 21 cfr part 803.A lot history review could not be performed as the lot number is unk.The investigation is inconclusive as the sample was not returned.The definitive root cause could not be determined based upon the available info.It is unk if patient and/or procedural issues contributed to the reported event.The info provided by bard represents all of the known info at this time.Despite good faith efforts to obtain additional info, the complaint/ reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

• Brand Name: UNK CONQUEST PTA BALLOON DILATATION CATHETER
• Type of Device: DQY
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; tempe AZ
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: bryan vogel ; 1625 west 3rd st.; tempe, AZ 85281 ; 4808949515
• MDR Report Key: 4781735
• MDR Text Key: 5817955
• Report Number: 2020394-2015-00398
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 08/29/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK CONQUEST
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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