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

Model Number	DR4074
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 three malfunctions; therefore, a lot history review will be performed.The sample was returned to the manufacturer for two malfunctions and the remaining one sample was discarded, and the company is still investigating the issue at this time.
Event or Problem Description
This report summarizes three malfunction.A review of the reported information indicated that model dr4074 pta balloon dilatation catheter allegedly experienced balloon rupture.This information was received from various sources.These malfunctions involved three patients with no consequences.Two malfunctions involved (b)(6) year old male and the remaining one patient's age, weight and gender were not provided.
Event or Problem Description
This report summarizes three malfunctions.A review of the reported information indicated that model dr4074 pta balloon dilatation catheter allegedly experienced balloon rupture.This information was received from various sources.These malfunctions involved three patients with no consequences.Two malfunctions involved 56 year old male and the remaining one patient's age, weight and gender were not provided.
Additional Manufacturer Narrative
H10: the lot number was provided for the three reported malfunctions; therefore, a lot history reviews were performed.The sample was returned to the manufacturer for two malfunctions and the remaining one sample was discarded.Out of three malfunctions, two are confirmed for the alleged balloon rupture issue.The remaining malfunction is inconclusive for the reported balloon rupture as the device was not returned.A definitive root cause could not be determined based upon available information.The devices are labeled for single use.

• Brand Name: DORADO 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: 10752913
• Report Number: 2020394-2020-06243
• Device Sequence Number: 3931860
• Product Code: DQK
• UDI-Device Identifier: 00801741058974
• UDI-Public: (01)00801741058974
• 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): 01/12/2021

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: No Information
• Device Model Number: DR4074
• Device Catalogue Number: DR4074
• Device Lot Number: 93YD0151, 93QD0033, 93QD0147
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 01/13/2021
• Patient Sequence Number: 1