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

Model Number	AT75264
Medical Device Problem Codes	Break (1069); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 12/2022).
Event or Problem Description
It was reported that during an angioplasty procedure through femoral artery, the pta balloon allegedly separated from the connecting pole.The procedure was completed using another balloon.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a device history record review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.Two electronic photos were provided and reviewed.The photo shows the atlas pta balloon which appeared to be bloody.A circumferential break was noted at the glue joint of the balloon and material rupture was noted on the balloon.Therefore, based on the photo review, the reported break and identified material rupture can be confirmed.A definitive root cause could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 12/2022).H11: section a through f ¿ the information provide 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.H3 other text : device not returned.
Event or Problem Description
It was reported that during an angioplasty procedure through femoral artery, the pta balloon allegedly separated from the connecting pole.The procedure was completed using another balloon.There was no reported patient injury.

• Brand Name: ATLAS PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11320236
• Report Number: 2020394-2021-00232
• Device Sequence Number: 14273790
• Product Code: DQY
• UDI-Device Identifier: 00801741062582
• UDI-Public: (01)00801741062582
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2021

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 Model Number: AT75264
• Device Catalogue Number: AT75264
• Device Lot Number: GFDY3728
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2021
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 02/12/2021
• Supplement Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 41 YR