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

Model Number ATG80164

Device Problems Break (1069); Deflation Problem (1149); Difficult to Remove (1528)

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

Event Date 07/12/2022

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.However, an image was provided for review.The investigation of the reported event is currently underway.(expiry date: 02/2025).

Event Description

It was reported that during an angioplasty procedure via upper arm fistula for the treatment of brachiocephalic stenosis, the pta balloon allegedly failed to deflate completely.It was further reported that the a needle was used to deflate the balloon.Reportedly the balloon and the sheath removed together.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one radio graphic image was reviewed.The fluoroscopic image centered around the left chest is reviewed.This image shows wire access likely arising from the left upper extremity and terminating near the caval-atrial junction.Therefore, one can deduce that the wire is likely within the central venous system.It appears that there is a partially inflated balloon likely within the left subclavian vein.The complaint regarding inflation issues cannot be confirmed from the provided image, which shows a partially inflated angioplasty balloon likely within the left subclavian vein.One atlas gold pta dilatation catheter loaded onto an unknown sheath was returned for evaluation.On visual evaluation of the device, the balloon was inverted and noted to have a bond joint break from the catheter and got separated from the proximal end, exposing the inner guide wire lumen but still attached to the distal of the catheter.Both the marker bands were present.No other specific anomalies were noted.No functional testing was performed due to the condition of the device.Therefore, the investigation for the reported deflation issue remains inconclusive as no functional testing was conducted due to the condition of the device returned for evaluation.The reported event also couldn't be confirmed based on the provided radiographic image as no objective evidence could be observed.However, the investigation is confirmed for the identified bond joint break as the balloon was noted to be partially detached from the proximal bond joint.The investigation is also confirmed for the identified difficult to remove as the balloon was loaded with an unknown sheath and returned for evaluation.A definitive root cause for the reported deflation issue and identified bond joint break, difficult to remove 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.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.H3 other text : see h10.

Event Description

It was reported that during an angioplasty procedure via upper arm fistula to treat brachiocephalic stenosis, the pta balloon allegedly failed to deflate completely.It was further reported that a needle was used to deflate the balloon.Reportedly, the balloon and the sheath was removed together as one unit.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: 15155045
• MDR Text Key: 298980873
• Report Number: 2020394-2022-00633
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741060816
• UDI-Public: (01)00801741060816
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181323
• 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: 09/01/2022

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: ATG80164
• Device Catalogue Number: ATG80164
• Device Lot Number: 93PG0155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 08/03/2022
• Supplement Dates Manufacturer Received: 09/07/2022
• Supplement Dates FDA Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2022
• 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: 62 YR
• Patient Sex: Male
• Patient Race: Black Or African American