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

Model Number AT75144

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

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

Event Date 06/06/2023

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 return of the sample is pending.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 02/2026).H11: section a through f: the information provide 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.

Event Description

It was reported that during an angioplasty procedure in iliac vein, the pta balloon allegedly burst at 18atm when performing multiple inflations.There was no reported patient injury.

Event Description

It was reported that during an angioplasty procedure in iliac vein, the pta balloon allegedly burst at 18 atm when performing multiple inflations.There was no reported patient injury.

Manufacturer Narrative

H10: 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 returned for evaluation.Peeled pebax and unraveling fibers were able to be observed on the balloon; no other anomalies were noted during the visual evaluation.On the functional testing, the balloon was inflated up to 6 atm with an in-house presto inflation device and no leak was noted.Then balloon was inflated to 18 atm as reported by user balloon burst was observed.Under microscopic observation, a large longitudinal rupture was noted in the balloon.No other functional testing was performed.Two photos were provided and reviewed.Both the photos show the balloon within a plastic bag and the balloon appeared to be bloody and in deflated condition, peeled pebax, unravelling fibers were able to be observed on the balloon.No other objective evidence for balloon rupture couldn¿t be noted on the submitted photo.From the submitted photos, no evidence of balloon rupture was observed, but peeled pebax and unraveling fibers can be observed, and during the returned sample analysis, longitudinal balloon rupture was noted under microscopic observations.Hence, the investigation confirms the reported balloon rupture and the identification of peeled pebax and unraveling fibers, respectively.A definitive root cause for the reported balloon rupture and identified peeled pebax and unraveling fibers could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 02/2026).H11: section a through f: the information provide 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: 17253780
• MDR Text Key: 318350758
• Report Number: 2020394-2023-00483
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741062438
• UDI-Public: (01)00801741062438
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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,Followup
• Report Date: 09/29/2023

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: GFGZ1211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2023
• Initial Date FDA Received: 07/04/2023
• Supplement Dates Manufacturer Received: 09/28/2023
• Supplement Dates FDA Received: 09/29/2023
• 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