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

Model Number AT75124

Device Problems Crack (1135); Deflation Problem (1149); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2018

Event Type  malfunction  

Manufacturer Narrative

No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: (b)(6) 2021).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 during an angioplasty procedure in the right subclavian vein, the pta balloon allegedly had difficulty deflating.It was further reported that the balloon had issues retracting through the sheath.No further treatment was needed.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: the device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.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: the device and the user's introducer sheath were returned for evaluation.A visual inspection found the cracks in the inflation luer of the device.At attempt was made to inflate the device and leaking was noted through the cracks in the inflation luer, preventing the device from being fully inflated or holding pressure.Therefore, the investigation is inconclusive for the reported deflation issue as the balloon was unable to be fully inflated due to the cracks in the luer.However, the investigation is confirmed for cracks in the inflation luer leading to inflation issues.The investigation is also confirmed for the reported retraction issue as the distal tip of the returned sheath was buckled and damaged.It is possible that the cracks in the inflation luer contributed to the reported deflation issue, as the cracks resulted in an inflation issue during functional testing.It is also possible that a deflation issue would lead to retraction issues through the sheath.However, the definitive root cause for the reported or identified issues 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.H10: d4 (expiry date: 06/2021) h6 (trending device code: 1310 - inflation issue).

Event Description

It was reported that during an angioplasty procedure in the right subclavian vein, the pta balloon allegedly had difficulty deflating.It was further reported that the balloon had issues retracting through the sheath.No further treatment was needed.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: 7877571
• MDR Text Key: 120535809
• Report Number: 2020394-2018-01700
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741062407
• UDI-Public: (01)00801741062407
• 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: 01/03/2019

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: AT75124
• Device Catalogue Number: AT75124
• Device Lot Number: GFCT2212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Initial Date Manufacturer Received: 08/20/2018
• Initial Date FDA Received: 09/14/2018
• Supplement Dates Manufacturer Received: 12/07/2018
• Supplement Dates FDA Received: 01/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 97