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

Model Number	ATG80166
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); 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	01/13/2023
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.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiration date: 10/2025).
Event or Problem Description
It was reported that during a venous angioplasty procedure for 42-year-old patient with post-thrombotic abnormalities cavo-bi-iliac, the balloon allegedly ruptured iliacally on the right at less than 10 atm pressure.It was further reported that because of the proximal attachment and giving some traction, contrast residue came out and the entire balloon of the shaft allegedly got torn off.Reportedly, the balloon part stuck somewhere to the right iliac.Snare device was used to remove the entire balloon component via the right internal jugular vein.The procedure was completed using another device.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.During visual evaluation, the balloon was noted to be completed detached and inverted, leaving the inner guidewire lumen exposed.No anomalies were noted to the luers y-body.No functional testing was performed due to the condition of the sample.One photo was provided and reviewed.The photo shows a portion of the atlas gold pta dilatation catheter with the balloon detached from it.Therefore, the investigation is confirmed for the reported balloon detachment as the balloon was noted to be detached from the catheter from both the photo review and the returned sample.However, the investigation is inconclusive for the reported balloon rupture and removal difficulty as no evidence of the failures could be determined.A definitive root cause for the alleged balloon rupture, balloon detachment and removal difficulty 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 (expiration date: 10/2025).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.
Event or Problem Description
It was reported that during a venous angioplasty procedure, the balloon allegedly ruptured iliacally on the right at less than 10 atm pressure.It was further reported that because of the proximal attachment and giving some traction, contrast residue came out and the entire balloon of the shaft allegedly got torn off.Reportedly, the balloon part stuck somewhere to the right iliac.Snare device was used to remove the entire balloon component via the right internal jugular vein.The procedure was completed using another device.The current status of the patient is unknown.

• 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: 16359375
• Report Number: 2020394-2023-00060
• Device Sequence Number: 6845749
• Product Code: DQY
• UDI-Device Identifier: 00801741060830
• UDI-Public: (01)00801741060830
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 03/13/2023

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: ATG80166
• Device Catalogue Number: ATG80166
• Device Lot Number: 93XG0014
• 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: 01/16/2023
• Supplement Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 02/11/2023
• Supplement Report FDA Received Date: 04/15/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Unknown