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

Model Number	U415074RX
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
The lot number was provided for the malfunction; therefore, a lot history review is currently being performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model u415074rx pta balloon dilatation catheter allegedly experienced material rupture.This information was received from one source.Of the one material rupture, one involved patients with no patient consequences.The patient was a 70 year old male and their weight information was not provided.
Additional Manufacturer Narrative
H10: this malfunction was determined to be reportable as a malfunction on 12/3/2019 and was reported to the fda through the quarterly voluntary malfunction summary reporting program.Mdr 2020394-2020-00221 was submitted and accepted by the fda on 01/14/2020.New information was received for this event on (b)(6) 2020 and the file was reassessed and determined to be not reportable; however, since an mdr has already been submitted, the file will remain reportable as a malfunction and a supplemental mdr will be sent to capture this change.H10: the lot number was provided for the malfunction; therefore, a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H10:g4 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.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model u415074rx pta balloon dilatation catheter allegedly experienced material rupture.This information was received from one source.Of the one material rupture, one involved patients with no patient consequences.The patient was a 70 year old male and their weight information was not provided.

• Brand Name: ULTRAVERSE RX 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: 9587136
• Report Number: 2020394-2020-00221
• Device Sequence Number: 3389811
• Product Code: LIT
• UDI-Device Identifier: 00801741058103
• UDI-Public: (01)00801741058103
• 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): 04/06/2020

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: U415074RX
• Device Catalogue Number: U415074RX
• Device Lot Number: CMCR0260
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 04/06/2020
• Patient Sequence Number: 1