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

Model Number	RV135610
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 device has been returned for evaluation, for the one reported event.The company is still investigating the issue at this time.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction event.A review of the events indicated that model rv135610 pta dilatation catheter allegedly ruptured.This report was received from one sources.The device was used inside the patient, with no reported patient injury.The patient was a (b)(6) year-old male, of (b)(6) kgs.
Additional Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review was performed.The device has been returned for evaluation; the investigation is inconclusive for the reported balloon rupture, as the balloon was unable to be inflated due to substance in the inflation hub and inflation lumen.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 one malfunction event.A review of the events indicated that model rv135610 pta dilatation catheter allegedly ruptured.This report was received from one sources.The device was used inside the patient, with no reported patient injury.The patient was a sixty-six year-old male, of sixty-nine kgs.

• Brand Name: RIVAL 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: 8519480
• Report Number: 2020394-2019-00342
• Device Sequence Number: 1839440
• Product Code: LIT
• UDI-Device Identifier: 00801741063732
• UDI-Public: (01)00801741063732
• 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): 07/23/2019

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: RV135610
• Device Catalogue Number: RV135610
• Device Lot Number: GFCR0698
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1