MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ATLAS PTA BALLOON DILATION CATHETER

Catalog Number AT75204

Device Problems Material Rupture (1546); Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/21/2014

Event Type  malfunction  

Event Description

It was reported that during inflation (atm unk) , the pta balloon appeared to be longer than as indicated on the package label.There was no reported retraction difficulty through the sheath.There was no reported pt injury.

Manufacturer Narrative

A complete mfg review could not be performed as the lot number is unk.The device was returned.The investigation is unconfirmed for a device markings issue, as the returned balloon met the spec of a 20mm x 40cm balloon and the balloon hub was marked as a 20mm x 40cm balloon.The balloon met the specs of a 4cm length balloon when measured from the proximal to distal marker bands.The investigation is confirmed for a circumferential balloon rupture.Potential factors which may have caused or contributed to the reported issue have been considered.It is unlikely that the atlas balloon was manufactured to be 6cm in length, as there are no atlas balloons that have a spec of 6cm in length with a 20mm balloon diameter.The length of the balloon body/barrel is measured from the horizontal distance between the cone-to-body transition shoulders of the balloon.The balloon body length does not include the proximal and distal cones.It is unk whether the user was aware that the balloon body length measurement does not include the proximal and distal cones.It is unk if procedural issues contributed to the reported event.The root cause for the balloon rupture could not be determined based upon the available info.

• Brand Name: ATLAS PTA BALLOON DILATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; tempe AZ
• Manufacturer (Section G): C.R. BARD, INC; 289 bay rd; queensbury NY 12804 204
• Manufacturer Contact: brett curtice ; 1625 west 3rd st; tempe, AZ 85281 ; 4808949515
• MDR Report Key: 4781271
• MDR Text Key: 5815647
• Report Number: 2020394-2015-00397
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/24/2014

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: AT75204
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/01/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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