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

Model Number ATG80144

Device Problems Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/13/2023

Event Type  Injury  

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: 02/2026) .

Event Description

It was reported that during an angioplasty procedure in the mid basilic vein arteriovenous fistula stenosis via distal basilic vein arteriovenous fistula, the pta balloon allegedly burst at 14 atm.It was further reported that the balloon was allegedly separated from the shaft.Furthermore, there was difficulty in retracting the balloon thru the introducer sheath as the balloon sheared off the catheter and the balloon did not come out.Reportedly, the patient was injured due to rupture and the balloon could not be retrieved which required deployment of two additional stents to exclude the foreign body.The current status of the patient is unknown.

Event Description

It was reported that during an angioplasty procedure in the mid basilic vein arteriovenous fistula stenosis via distal basilic vein arteriovenous fistula, the pta balloon allegedly burst at 14 atm.It was further reported that the balloon was allegedly separated from the shaft.Furthermore, there was difficulty in retracting the balloon through the introducer sheath as the balloon sheared off the catheter and the balloon did not come out.Reportedly, the patient was injured due to rupture and the balloon could not be retrieved which required deployment of two additional stents to exclude the foreign body.The current status of the patient is unknown.

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 dilatation catheter was returned for evaluation.The balloon was noted to be detached from the catheter, exposing the inner guide wire lumen.The detached balloon was not returned for evaluation.The glue bullet was not seated in the correct position.No other anomalies were noted with the returned device during the visual evaluation.No functional testing was performed due to the condition of the device.As the balloon was completely detached from the catheter and not returned for evaluation, no objective evidence for rupture or evidence of removal difficulty could be observed.Hence, the investigation can only be confirmed about the reported balloon detachment and the investigation remains inconclusive for the reported balloon rupture and difficulty to remove it.A definitive root cause for the reported balloon rupture, balloon detachment and 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.H10: d4 (expiry date: 02/2026), 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.

• 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: 16711403
• MDR Text Key: 313007873
• Report Number: 2020394-2023-00238
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741060755
• UDI-Public: (01)00801741060755
• 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: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ATG80144
• Device Catalogue Number: ATG80144
• Device Lot Number: 93PH0094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic