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

Model Number	V1840200
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported malfunctions, one device was returned and the other malfunction only returned product packaging and label, but no actual device.The company is still investigating the issue at this time.The devices are labeled for single use.
Event or Problem Description
This report summarizes two (2) malfunction.A review of the reported information indicated that model v1840200 pta balloon dilatation catheter allegedly experienced a deflation issue.This information was received from various sources.The two malfunctions involved patients with no known impact to the patient.One patient was an (b)(6) year-old male and the other was a (b)(6) year-old female, weights not provided.
Additional Manufacturer Narrative
H10: the lot number was provided for the two malfunctions, and lot history reviews were performed.For the reported malfunctions, one device was returned and the other malfunction only returned product packaging and label, but no actual device.Deflation issue was not identified for either malfunction.The devices are 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.
Event or Problem Description
This report summarizes two (2) malfunction.A review of the reported information indicated that model v1840200 pta balloon dilatation catheter allegedly experienced a deflation issue.This information was received from various sources.The two malfunctions involved patients with no known impact to the patient.One patient was an 83 year-old male and the other was a 53 year-old female, weights not provided.

• Brand Name: VASCUTRAK 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: 8824314
• Report Number: 2020394-2019-01844
• Device Sequence Number: 14088558
• Product Code: PNO
• UDI-Device Identifier: 00801741061592
• UDI-Public: (01)00801741061592
• 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): 10/17/2019

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: V1840200
• Device Catalogue Number: V1840200
• Device Lot Number: GFCZ2833, GFDP1455
• 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: 10/17/2019
• Patient Sequence Number: 1