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

Catalog Number	AT75144
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly had a leak from the balloon.It was further reported that the balloon was removed from the patient.The procedure was completed using another device.There was no reported patient 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, photos were provided for review.The investigation of the reported event is currently underway.(expiration date: 11/2026).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.
Additional Manufacturer Narrative
H10: additional information was received, the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction/serious injury.H10: b5, d4 (expiration date: 11/2026), g3.H11: d2b (dqy;lit), h6 (device).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 had a leak from the balloon.It was further reported that the balloon was allegedly not ruptured and then it was removed from the patient.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, the pta balloon allegedly had a leak from the balloon.It was further reported that the balloon was allegedly got ruptured and then it was removed from the patient.The procedure was completed using another device.There was no reported patient injury.
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: two photos were received and reviewed.In the first photo, a liquid droplet was noted at the balloon tip, but the photo was unclear, and no other anomalies could be observed.The second photo shows the product details which matches with trackwise information.One atlas pta dilatation catheter was received for evaluation.During visual analysis, the sample appeared to have residue throughout and rewrap tool was present over the proximal end of the balloon.No other anomalies were noted.On functional testing, an in-house presto inflation device was used for inflation and a leak in the distal end of balloon was noted.Further, the balloon fibers were striped and upon microscopic observation, two pinhole ruptures on the balloon were noted.No other testing was performed.Therefore, the investigation is confirmed for the reported leak and identified balloon rupture since pinhole ruptures were identified on the balloon from which water was noted to leak.A definitive root cause for the identified balloon rupture and reported leak 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.H11: b5, d4 (unique identifier (udi) #), d2b (dqy;lit), h2, h6 (device, method, 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.

• 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: 19706756
• Report Number: 2020394-2024-00993
• Device Sequence Number: 7751239
• Product Code: DQY
• UDI-Device Identifier: 00801741062438
• UDI-Public: (01)00801741062438(11)231206(17)261128(10)GFHX2336
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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,Followup,Followup
• Report Date (Section B): 09/12/2024

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: AT75144
• Device Lot Number: GFHX2336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 06/19/2024; 09/09/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 07/17/2024; 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2023
• 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