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

Catalog Number	AT75244
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2024
Type of Reportable Event	Malfunction
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 pta atlas dilatation balloon was received for evaluation without the catheter.During evaluation the balloon was detached from the catheter, where the catheter part was not received and balloon was still attached with inner guidewire lumen could be observed.Further complete circumferential break was noted to the proximal end of the inner lumen.Also throughout the balloon bunching could be noted.No other functional testing was performed due to the condition of device.One photo was received and reviewed.In the provided photo only the balloon was seen where the remaining part of the catheter was not visible.Further deformation and balloon bunching could be identified in the distal end.No other anomalies were noted in the photo.Based on the photo review no evidence of balloon rupture was noted and it was observed that the balloon was noted to be bunched which was also confirmed during the visual evaluation of returned balloon.Balloon was detached from the catheter was identified.And functional testing also could not be performed.Hence the investigation was confirmed for the identified balloon detachment from the catheter, balloon bunching issues and inconclusive for the reported balloon rupture.A definitive root cause for the reported balloon rupture, identified balloon detachment and balloon bunching issue 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: 07/2026).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, the pta balloon allegedly ruptured and cannot be used.The procedure was completed using another balloon.There was no reported patient injury.

• Brand Name: ATLAS
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 19131660
• Report Number: 2020394-2024-00531
• Device Sequence Number: 6825790
• Product Code: DQY
• UDI-Device Identifier: 00801741062568
• UDI-Public: (01)00801741062568
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K120971
• 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
• Report Date (Section B): 04/16/2024

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 Catalogue Number: AT75244
• Device Lot Number: GFHT2210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 04/18/2024
• 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