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

Model Number ATG80144

Device Problems Break (1069); Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)

Patient Problems Vascular Dissection (3160); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/06/2023

Event Type  Injury  

Event Description

It was reported that during a angioplasty procedure, the balloon allegedly separated from the shaft.It was further reported that balloon allegedly burst in cephalic arch.Reportedly, the balloon was difficult to remove from introducer sheath and removed a one unit.A dissection of the venotomy site to remove balloon was done with subsequent closure and procedure was completed through new venotomy site.The current status of the patient is unknown.

Manufacturer Narrative

H10: 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.H10: d4 (expiry date: 03/2026).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 : device pending return.

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured in the cephalic arch.It was further reported that the balloon allegedly separated from the trailing edge of the shaft.Reportedly, the balloon was difficult to remove from the introducer sheath and was removed together as one unit.Further, a dissection of the venotomy site was done to remove the balloon with subsequent closure and procedure was completed through new venotomy site.The current status of the patient is unknown.

Manufacturer Narrative

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 received for evaluation.During visual evaluation, balloon material was noted on the proximal glue weld, indicating that the balloon had been attached.The inner guidewire lumen was still intact with the balloon that was partially inverted at its distal end.No kinks were noted to the catheter.An unknown sheath was loaded over the inner guidewire lumen with glue bullet seated incorrectly.No functional testing was performed due to the condition of the sample.Therefore, the investigation is inconclusive for the reported balloon rupture as no functional testing could be performed due to the condition of the returned device.The investigation is unconfirmed for the reported detachment as no complete detachment was noted on the device.The investigation is confirmed for the reported sheath removal difficulty as the device was returned with an introducer sheath loaded over it.The investigation is confirmed for the identified break as the balloon was seen still attached to the inner guidewire lumen at its distal end.A definitive root cause for the alleged balloon rupture, sheath removal difficulty, balloon detachment and identified break 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.D4 (expiry date: 03/2026).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.

• Brand Name: ATLAS GOLD
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 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: 16866136
• MDR Text Key: 314533101
• Report Number: 2020394-2023-00314
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• 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: 93QH0055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2023
• 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