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

Catalog Number AT75144

Device Problem Deflation Problem (1149)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/05/2024

Event Type  malfunction  

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 11/2026) h11: section a through f - the information provided by bd 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 bd.

Event Description

It was reported that during an angioplasty procedure, the pta balloon was allegedly unable to be deflated.Reportedly, the balloon was pulled as close to the neck area and was punctured with an 18f needle under ultrasound guidance to deflate the balloon.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.One photo was reviewed.The photo shows the balloon to be in partially inflated condition and appearing bloody.No other anomalies were noted and no other objective evidence for the reported event was observed.As no objective evidence was noted on the submitted photo, the investigation remains inconclusive for the reported deflation issue.A definitive root cause for the reported deflation issue could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.Expiry date: 11/2026.The information provided by bd 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 bd.

Event Description

It was reported that during an angioplasty procedure, the pta balloon was allegedly unable to be deflated.Reportedly, the balloon was pulled as close to the neck area and was punctured with a needle under ultrasound guidance to deflate the balloon.There was no reported patient injury.

• Brand Name: ATLAS
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 19018090
• MDR Text Key: 339091421
• Report Number: 2020394-2024-00419
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741062438
• UDI-Public: (01)00801741062438
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K120971
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AT75144
• Device Lot Number: GFHX2336
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• 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