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

Model Number	AT75146
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One device was returned for evaluation.The lot number was provided and the lot history review is being performed.The investigation is currently underway.
Event or Problem Description
This report summarizes one malfunction.The information reviewed indicated that model at75146 pta balloon dilatation catheter allegedly ruptured.This report was received from one source.This device was used in a (b)(6) year old male patient.There was no reported patient injury.
Event or Problem Description
This report summarizes one malfunction.The information reviewed indicated that model at75146 pta balloon dilatation catheter allegedly ruptured.This report was received from one source.This device was used in a 60 year old male patient.There was no reported patient injury.
Additional Manufacturer Narrative
H10: the lot number for the malfunction was provided and a lot history review was performed.The device has been returned for evaluation; the evaluation identified pinhole balloon rupture.Based upon the available information, a definitive root cause is unknown.The device is labeled for single use.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.

• 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: 9194968
• Report Number: 2020394-2019-03974
• Device Sequence Number: 3934987
• Product Code: LIT
• UDI-Device Identifier: 00801741062445
• UDI-Public: (01)00801741062445
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2020

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: No Information
• Device Model Number: AT75146
• Device Catalogue Number: AT75146
• Device Lot Number: GFCN0730
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 01/06/2020
• Patient Sequence Number: 1