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

Model Number	ATG120124
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2023
Type of Reportable Event	Malfunction
Additional 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.However, a video was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 06/2025).H11: section a through f ¿ the information provided 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.
Event or Problem Description
It was reported that during an angioplasty procedure via bilateral femoral vein, the pta balloon allegedly ruptured at 8 atm.It was further reported that the balloon body detached from the catheter during removal.Reportedly, the balloon body was removed using a snare.The procedure was completed using another device.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure in the bilateral iliac vein via the bilateral femoral vein, the pta balloon allegedly ruptured at 8 atm.It was further reported that the balloon body detached from the catheter during removal.Reportedly, snare was used to remove the balloon segment and withdraw it with the vascular sheath together from the body.The procedure was completed using another device.There was no reported patient injury.
Additional 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 have detached completely from the catheter and noted to be prolapsed and inverted.Glue bullet was noted to be incorrectly seated.No other specific anomalies during the visual evaluation.No functional testing was performed due to the condition of the device.One radio graphic video reviewed.The video loop demonstrates balloon being dilated at the end of a iliac vein stent.The balloon ruptures toward the end of maximum dilation.The balloon is being dilated in a self-expanding stent and at the end of the stent.The stent struts can deform and puncture the balloon as well as over expansion can cause rupture.After rupture, the balloon can get caught on the struts requiring retrieval.The submitted radiographic video confirms the evidence of balloon rupture as the balloon ruptures toward the end of maximum dilation could be observed and the returned device for analysis also confirms the balloon is noted to be detached and the returned balloon noted to be inverted and prolapsed.Hence, the investigation confirms all the reported events such as balloon rupture, balloon detachment and difficulty with removal of the detached balloon respectively.A definitive root cause for the reported balloon rupture, balloon detachment and difficulty with removal of the detached balloon 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 (expiration date: 06/2025), g3.H11: section a through f ¿ the information provided 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
• Common Device Name: 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: 16982643
• Report Number: 2020394-2023-00353
• Device Sequence Number: 17849717
• Product Code: DQY
• UDI-Device Identifier: 00801741060700
• UDI-Public: (01)00801741060700
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K181323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2023

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
• Operator of Device: Health Professional
• Device Model Number: ATG120124
• Device Catalogue Number: ATG120124
• Device Lot Number: 93TG0031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/26/2023
• Supplement Date Received by Manufacturer: 07/24/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown