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

Model Number ATG120204

Device Problems Deflation Problem (1149); Inflation Problem (1310); Material Deformation (2976)

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

Event Date 06/27/2022

Event Type  malfunction  

Event Description

It was reported that prior to an angioplasty procedure, the balloon allegedly had abnormal inflation.It was further reported that the balloon allegedly had deflation problem.The procedure was completed using another device.There was no patient contact.

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 02/2024).

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 gold pta catheter was returned for evaluation.No specific anomalies were noted during the visual evaluation.In the functional testing, the device was inflated with an in-house presto inflation device, and the balloon inflated up to 16 atm without any issue and maintained pressure and shape.Further, the balloon took 20 seconds to deflate completely , which is within the acceptable range as per the product performance speciation.Therefore, the investigation into the reported inflation issue and material deformation was unconfirmed as the balloon inflated and maintained shape and pressure without any issues.The investigation into the reported deflation issue was unconfirmed as the balloon inflated and deflated without any issue and the deflation time was within the acceptable range as per the product performance specification.A definitive root cause for the reported inflation issue, material deformation 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: 02/2024), g3.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 prior to an angioplasty procedure, the balloon allegedly had abnormal inflation.It was further reported that the balloon allegedly had deflation problem.The procedure was completed using another device.There was no patient contact.

• Brand Name: ATLAS GOLD
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): FUTUREMATRIX INTERVENTIONAL; 1605 enterprise street; athens 75751
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15101363
• MDR Text Key: 296586237
• Report Number: 2020394-2022-00605
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741060946
• UDI-Public: (01)00801741060946
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K181323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/09/2022

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: ATG120204
• Device Catalogue Number: ATG120204
• Device Lot Number: 93PG0149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 07/26/2022
• Supplement Dates Manufacturer Received: 09/09/2022
• Supplement Dates FDA Received: 09/13/2022
• 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