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

Catalog Number	ATG80144
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly sheared off shaft when removing it.It was also reported that the pta balloon allegedly had difficulty in removing.It was further reported that the physician had to do a cut-down on the vein to remove the balloon.The current status of the patient is reported to be stable.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records will be performed.The return of the sample is pending.However, a photo was provided for review.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.
Additional 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: the physical device was not returned for evaluation.One photo was provided and reviewed.The photo shows the balloon catheter and sheath which are held by the medical professional.It was further observed that the balloon was noted to be completely detached from the catheter shaft and only some portion of detached balloon was noted to be distal end of the introducer sheath in inverted condition.The catheter shaft shows the exposed inner guide wire lumen due to the balloon detachment; both the marker bands are present at its intended location.The glue bullet of the catheter shaft was noted to be pulled out from the porthole.No other anomalies noted.As the submitted photo confirms the evidence of complete balloon detachment and the detached balloon still loaded within the sheath, the investigation was confirmed for the reported balloon detachment and balloon removal difficulty through the sheath.A definitive root cause for the reported balloon detachment and balloon removal difficulty through the sheath could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 03/2026), g3, h6 (method).H11: h6 (result, conclusion).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.H3 other text : device not returned.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly sheared off the shaft when removing it through a sheath.It was further reported that the pta balloon allegedly had difficulty in removing.Furthermore, the physician had to do a cut-down on the vein to remove the balloon.The current status of the patient is reported to be stable.

• 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: 18824351
• Report Number: 2020394-2024-00294
• Device Sequence Number: 20803091
• Product Code: DQY
• UDI-Device Identifier: 00801741060755
• UDI-Public: (01)00801741060755
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K181323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2024

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 Catalogue Number: ATG80144
• Device Lot Number: 93QH0055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2024
• Supplement Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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