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

Catalog Number	ATG80124
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.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 in the axillary graft, the pta balloon allegedly ruptured inside the patient's body.It was further reported that upon bringing the balloon back into the sheath over the wire, the balloon component caught at the sheath tip and the balloon shaft allegedly broke off inside the body.Furthermore, the sheath was brought out over the wire and with the balloon embedded in the sheath tip, the sheath and the balloon were removed as one unit.Reportedly, a snare was used to retrieve the retained portion of the balloon from the patient's body.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 device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiry date: 08/2026), g3 h11: d4 (medical device lot number), h6 (method) 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 in the axillary graft, the pta balloon allegedly ruptured inside the patient's body.It was further reported that upon bringing the balloon back into the sheath over the wire, the balloon component caught at the sheath tip and the balloon shaft allegedly broke off inside the body.Furthermore, the sheath was brought out over the wire and with the balloon embedded in the sheath tip, the sheath and the balloon were removed as one unit.Reportedly, a snare was used to retrieve the retained portion of the balloon from the patient's body.There was no reported patient injury.
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.A complete circumferential detachment was noted to the distal end of the catheter shaft.The distal segment of the catheter was returned attached to the balloon.Due to the condition of the sample, functional testing was not performed.Therefore, the investigation is confirmed for the reported detachment as the device was received completely detached in two segments.However, the investigation is inconclusive for the reported balloon rupture as no functional testing of the balloon could be performed due to the condition of the returned device.The investigation is also inconclusive for the reported removal difficulty as no objective evidence was provided.A definitive root cause for the alleged balloon rupture, detachment and removal difficulty 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: b5, d4 (expiration date: 08/2026).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 in the axillary graft, the pta balloon allegedly ruptured inside the patient's body.It was further reported that upon bringing the balloon back into the sheath over the wire, the balloon component caught at the sheath tip and the balloon shaft allegedly broke off inside the body.Furthermore, the sheath was brought out over the wire and with the balloon embedded in the sheath tip, the sheath and the balloon were removed as one unit.Reportedly, a snare was used to retrieve the retained portion of the balloon from the patient's body and placed a new sheath over the wire to finish the procedure.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: 18683041
• Report Number: 2020394-2024-00187
• Device Sequence Number: 17737266
• Product Code: DQY
• UDI-Device Identifier: 00801741060694
• UDI-Public: (01)00801741060694
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 04/25/2024

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: ATG80124
• Device Lot Number: 93VH0099
• 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: 01/13/2024
• Supplement Date Received by Manufacturer: 02/27/2024; 04/25/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 03/25/2024; 04/29/2024
• 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 Age: 73 YR
• Patient Sex: Male