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

Catalog Number	ATG120244
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure for an aortic valve replacement, via the femoral access, the pta balloon was allegedly found to be punctured with a hole.There was no reported patient injury.
Additional Manufacturer Narrative
H10: 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.H10: d4 (expiry date: 03/2026).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.
Additional Manufacturer Narrative
H10: additional information was received and 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.H10: d4 (expiry date: 03/2026), g3.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.Device pending return/.
Event or Problem Description
It was reported that during an angioplasty procedure for an aortic valve replacement, via the femoral access, the pta balloon was allegedly found to be punctured with a hole.There was no reported patient injury.
Additional Manufacturer Narrative
H10: additional information provided by the complainant indicated that there was no vessel damage, no detachment of the device, and no difficulty retracting the device through the introducer sheath; therefore, this event can be deemed a non-complicated balloon rupture and is no longer reportable.However, our firm received an fda email correspondence on 8-july-2024 from mdr data systems team, latania parker, indicating that the information (specifically the unique device identifier (udi) information in section d) of the previously submitted fda form 3500a, was incorrect and a request was made to submit supplemental report(s) with the entire udi number including the di and pi fields, all numbers, letters, parentheses, and symbols in the ¿unique device identifier (udi) #¿ fields.This supplemental report is in response to that request.H11: d2: medical device type-lit; dqy d4: medical device expiration date- 03/09/2026 d4: udi- (b)(4).H4: device manufacture date- 03/09/2023 g4: k122984;k181323.
Event or Problem Description
It was reported that during an aortic valve replacement angioplasty procedure in the femoral route, the balloon was allegedly punctured with a hole.The procedure was completed by using another device.There was no reported patient injury.

• 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: 18129844
• Report Number: 2020394-2023-01037
• Device Sequence Number: 6703301
• Product Code: DQY
• UDI-Device Identifier: 00801741061028
• UDI-Public: (01)00801741061028(11)230309(17)260309(10)93PH0195
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/16/2024

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 Expiration Date: 03/09/2026
• Device Catalogue Number: ATG120244
• Device Lot Number: 93PH0195
• 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: 10/17/2023
• Supplement Date Received by Manufacturer: 12/06/2023; 07/08/2024
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 01/05/2024; 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2023
• 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 Age: 59 YR
• Patient Sex: Male