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

Model Number AT75144

Device Problems Material Frayed (1262); Peeled/Delaminated (1454); Material Rupture (1546); Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2018

Event Type  malfunction  

Manufacturer Narrative

No hospital/medical records or medical images have been made available to the manufacturer.The lot number for the device was not provided; therefore, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.

Event Description

It was reported that during an angioplasty procedure in the cephalic arch, the pta balloon allegedly ruptured.There was no retraction issue through the sheath, no reported detached balloon fragments, and no vessel damage post balloon rupture.Another device was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: a complete manufacturing review could not be conducted, as the lot number was not reported for this device.Investigation summary: the device was returned for evaluation.A visual inspection found unraveled fibers on the barrel of the balloon.The balloon was inflated with an in-house inflation device and a pinhole rupture was noted on the balloon.Therefore, the investigation is confirmed for unraveled fibers and for a pinhole rupture.The definitive root cause for the identified unraveled fibers or pinhole rupture could not be determined based upon the available information.It is unknown if patient and/or procedural issues contributed to the reported event.The review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(removed device codes: 1262 - material frayed & 1454 peeled / delaminated; added device code: 1664 - unraveled material).

Event Description

It was reported that during an angioplasty procedure in the cephalic arch, the pta balloon allegedly ruptured.Another device was used to complete the procedure.There was no reported patient injury.

• Brand Name: ATLAS PTA DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8012019
• MDR Text Key: 125283042
• Report Number: 2020394-2018-01944
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741062438
• UDI-Public: (01)00801741062438
• Combination Product (y/n): N
• PMA/PMN Number: K120971
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/08/2019

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 Model Number: AT75144
• Device Catalogue Number: AT75144
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2018
• Initial Date Manufacturer Received: 10/01/2018
• Initial Date FDA Received: 10/28/2018
• Supplement Dates Manufacturer Received: 12/13/2018
• Supplement Dates FDA Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR