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

Model Number	ATG80124
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	09/07/2022
Type of Reportable Event	Serious Injury
Additional 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: 05/2025).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 or Problem Description
It was reported that during an angioplasty procedure, the balloon allegedly detached from the shaft.It was further reported that the balloon was difficult to be removed from the patient.Reportedly, the device caused occlusion at the level of the v.Pulmonalis.The current status of the patient is unknown.
Event or Problem Description
It was reported that during an angioplasty procedure, the balloon allegedly detached from the shaft.It was further reported that the balloon was difficult to be removed from the patient.Reportedly, the device caused occlusion at the level of the v.Pulmonalis.The current status of the patient is unknown.
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 received for evaluation with the balloon detached.During visual evaluation, the balloon was noted to be inverted and detached.The glue bullet was not seated correctly and inner guidewire lumen was noted to be exposed with marker bands present.No kinks were noted to the catheter shaft and no anomalies to the luers/y-body.No functional testing was performed due to the nature of the complaint.Therefore, the investigation is confirmed for the reported balloon detachment as the balloon was received detached from the catheter shaft.However, the investigation is inconclusive for the reported difficulty retrieving the detached balloon as the failure cannot be replicated for testing.A definitive root cause for the alleged balloon detachment and difficulty retrieving 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.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.

• Brand Name: ATLAS GOLD
• Common Device Name: 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: 15493248
• Report Number: 2020394-2022-00767
• Device Sequence Number: 13917347
• Product Code: DQY
• UDI-Device Identifier: 00801741060694
• UDI-Public: (01)00801741060694
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ATG80124
• Device Catalogue Number: ATG80124
• Device Lot Number: 93SG0090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2022
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 09/27/2022
• Supplement Report FDA Received Date: 12/01/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown