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

Catalog Number AT75124

Device Problems Deflation Problem (1149); Material Frayed (1262); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)

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

Event Date 01/19/2024

Event Type  malfunction  

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly refused to deflate.Further it was reported that the balloon was hyper inflated until it ruptured at 30 atm.There was no reported patient injury.

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiration date: 11/2026) h11: section a through f ¿ the information provided by bd represents all 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.H3 other text : device pending return.

Event Description

It was reported that during an angioplasty procedure in the abdominal aorta, the pta balloon allegedly refused to deflate.It was further reported that several attempts were made to deflate the balloon but were unsuccessful.Reportedly, the balloon was allegedly hyperinflated up to nearly double the 18 atm burst pressure until rupture and the balloon allegedly got ruptured at over 30 atm.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: one atlas pta dilatation catheter was received for evaluation.During visual analysis, material frayed of the balloon could be observed.No other anomalies were noted.On functional testing, an in-house inflation device was used for inflation.Further the balloon inflated, maintained pressure, and deflated without any issue could be observed.No evidence of balloon rupture could be observed.No other functional testing was performed.Per the reported event user reports the balloon was inflated above the rated burst pressure in order to deflate the balloon.However, during the return sample analysis no evidence of rupture noted on the balloon material and during the functional testing the balloon was inflated and deflated without any issue.Further during the visual evaluation, frayed fibers was observed on the material fiber.Therefore, the investigation was confirmed for the identified material frayed and reported over pressurization of balloon above rated burst pressure and the investigation remains unconfirmed for the reported deflation issue and balloon rupture.A definitive root cause for the identified material frayed and reported deflation, balloon rupture and over pressurization of balloon above rated burst pressure issues 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.(expiration date: 11/2026), g3, h6 (device) section a through f ¿ the information provided by bd represents all 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.

• Brand Name: ATLAS
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 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: 18738833
• MDR Text Key: 336864107
• Report Number: 2020394-2024-00237
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741062407
• UDI-Public: (01)00801741062407
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120971
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AT75124
• Device Lot Number: GFHY0291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2024
• 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