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

Model Number ATG120184

Device Problems Deflation Problem (1149); Inflation Problem (1310); Difficult to Remove (1528); Material Rupture (1546); Material Twisted/Bent (2981)

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

Event Date 10/25/2022

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 return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 05/2023).

Event Description

It was reported that during an angioplasty procedure in left femoral vein, the pta balloon allegedly failed to inflate.It was further reported that the balloon allegedly failed to deflate and bent.Reportedly, the balloon allegedly ruptured and difficult to remove.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 gold dilatation catheter was returned for evaluation.No kink or bent was noted on the returned device during the visual evaluation.During functional testing, the guide wire lumen of the catheter was flushed without any issue and an in-house guide wire was able to be inserted into the catheter without any issue.Then, the balloon was inflated with an in-house presto inflation device and the balloon was inflated up to 16 atm which maintained pressure with no leaks on the balloon.Further, the balloon was deflated which took 35 seconds, that was within the acceptable limit of the product performance specification.The balloon was then cut and it was discovered that the glue bullet was not properly seated.The guidewire was removed without issue.No further functional testing was performed.As a result, the investigation for the reported inflation issue is unconfirmed, as the balloon was able to inflate and maintain pressure during functional testing without incident.The investigation for the reported deflation issue is also unconfirmed, as the balloon was deflated without any issue and the time it took to deflate was within the acceptable limit of the product performance specification.The investigation for the reported bent catheter was also unconfirmed, as no kink or bend was noted during the visual evaluation of the returned device.However, the reported sheath removal issue remains inconclusive as the functional testing couldn¿t be performed for the sheath because the balloon was cut during the functional testing, although the inserted in-house guide wire was able to insert into the catheter and be removed without any issue.A definitive root cause for the reported inflation issue, deflation issue , catheter bent and sheath removal failure 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: b5, d4 (expiry date: 05/2023), 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 during an angioplasty procedure in the left femoral vein, the pta balloon allegedly failed to inflate.It was further reported that the balloon allegedly failed to deflate.Reportedly, the catheter was allegedly bent and the balloon was allegedly difficult to remove.The procedure was completed using another device.There was no reported patient injury.

• 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: 15821917
• MDR Text Key: 307613888
• Report Number: 2020394-2022-00904
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/16/2022

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: ATG120184
• Device Catalogue Number: ATG120184
• Device Lot Number: 93RE0034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2022
• Initial Date FDA Received: 11/17/2022
• Supplement Dates Manufacturer Received: 12/26/2022
• Supplement Dates FDA Received: 01/02/2023
• 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
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 53 KG