MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	U357574
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
Two of the devices have been returned for evaluation; the investigations for the two malfunctions with returned devices are currently underway.One device was not returned; therefore, the investigation for the malfunction without a returned device is inconclusive for material rupture.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes three malfunctions.A review of the reported information indicated that model u357574 pta balloon dilatation catheter allegedly experienced a material rupture.This information was received from various sources.The malfunction involved patients without consequence.One patient was reported to be male; all other age, weight, and sex information was not provided.
Event or Problem Description
This report summarizes three malfunctions.A review of the reported information indicated that model u357574 pta balloon dilatation catheter allegedly experienced a material rupture.This information was received from various sources.The malfunction involved patients without consequence.One patient was reported to be male; all other age, weight, and sex information was not provided.
Additional Manufacturer Narrative
H10: two of the three devices have been returned to bd for evaluation.Of the three malfunctions one investigation is confirmed for the identified leak and unconfirmed for the reported balloon rupture.One investigation is identified for balloon rupture.One device was not returned; therefore, the investigation for the malfunction without a returned device is inconclusive for material rupture.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.H11: h6(results, conclusion).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: ULTRAVERSE 035 PTA 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: 8823307
• Report Number: 2020394-2019-01814
• Device Sequence Number: 2838664
• Product Code: LIT
• UDI-Device Identifier: 00801741093456
• UDI-Public: (01)00801741093456
• 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): 10/14/2019

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: U357574
• Device Catalogue Number: U357574
• Device Lot Number: CMCP0072,CMDN0246
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 07/24/2019
• Supplement Report FDA Received Date: 10/14/2019
• Patient Sequence Number: 1