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

Model Number AT75144

Device Problems Deflation Problem (1149); Inflation Problem (1310)

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

Event Date 09/23/2022

Event Type  malfunction  

Manufacturer Narrative

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 : 06/2023).

Event Description

It was reported that during a angioplasty procedure via brachiocephalic fistula, the device was allegedly had inflation issue.It was further reported that the device allegedly had deflation issue.The procedure was completed using another device.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 along with a presto inflation device was returned for evaluation.No specific anomalies were noted during the visual evaluation.On the functional testing, the balloon was inflated with returned presto inflation.The balloon was inflated and maintained pressure and shape.Further, the balloon was deflated.No other functional testing was performed.Therefore, the investigation for the reported issues with inflation and deflation was unconfirmed as the balloon was inflated and deflated without any issue during the functional testing of the returned sample.A definitive root cause for the reported inflation and deflation issue 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 : 06/2023), g3, h6 (method).H11: h6 (result, conclusion).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.H3 other text : see h10.

Event Description

It was reported that during an angioplasty procedure via brachiocephalic fistula, the device allegedly had inflation issue.It was further reported that the device allegedly had deflation issue.The procedure was completed using another device.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 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: 15725484
• MDR Text Key: 307197485
• Report Number: 2020394-2022-00864
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741062438
• UDI-Public: (01)00801741062438
• 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: 11/25/2022

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: GFEU0120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 11/25/2022
• Supplement Dates FDA Received: 11/30/2022
• 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
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 84 KG