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

Model Number	VDA100184
Medical Device Problem Codes	Break (1069); Retraction Problem (1536); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to bd for evaluation.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.A review of the reported information indicated that model vda100184 pta balloon dilatation catheter allegedly experienced a material rupture and detachment.This information was received from one source.This malfunction did involve a patient with no patient injury.Age, weight, and gender were not provided for the patient.
Additional Manufacturer Narrative
H10: the lot number for the malfunction was provided and a lot history review was performed.The device was returned to bd for evaluation and identified glue bullet was stretched, balloon detached at the proximal end and inverted.Marker bands are present but not in the correct position, distal tip of the sheath is buckled.A definitive root cause could not be determined.The device is 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 one malfunction.A review of the reported information indicated that model vda100184 pta balloon dilatation catheter allegedly experienced a material rupture and detachment.This information was received from one source.This malfunction did involve a patient with no patient injury.Age, weight, and gender were not provided for the patient.
Additional Manufacturer Narrative
H10: the lot number for the malfunction was provided and a lot history review was performed.The device was returned to bd for evaluation; the investigation is confirmed for break (1069) and retreaction issue (1546), however it is inconclusive for the retraction issue (2907).A definitive root cause could not be determined.The device is 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 one malfunction.A review of the reported information indicated that model vda100184 pta balloon dilatation catheter allegedly experienced a break, material rupture, and detachment.This information was received from one source.This malfunction did involve a patient with no patient injury.Age, weight, and gender were not provided for the patient.

• Brand Name: VIDA PTV 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: 9210416
• Report Number: 2020394-2019-04097
• Device Sequence Number: 16908578
• Product Code: OMZ
• UDI-Device Identifier: 00801741090899
• UDI-Public: (01)00801741090899
• 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,Followup
• Report Date (Section B): 03/30/2020

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: VDA100184
• Device Catalogue Number: VDA100184
• Device Lot Number: 93XC0199
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 12/31/2019; 03/27/2020
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 01/08/2020; 04/01/2020
• Patient Sequence Number: 1