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

Model Number	VA8074
Medical Device Problem Codes	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
For the reported malfunction, 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 va8074 pta balloon dilatation catheter allegedly experienced material rupture and detachment.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The (b)(6) year old male patient was (b)(6) lb.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model va8074 pta balloon dilatation catheter allegedly experienced material rupture and detachment.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The 40 year old male patient was 165 lb.
Additional Manufacturer Narrative
H10: the lot number was provided and a lot history review was performed.The device was returned for evaluation and detachment was identified and material rupture is inconclusive.The definitive root cause is unknown.The device is labeled for single use.H10: g4 h11: h6 (results, conclusion) 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.

• Brand Name: VACCESS 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: 9210725
• Report Number: 2020394-2019-04099
• Device Sequence Number: 13565300
• Product Code: DQY
• UDI-Device Identifier: 00801741121319
• UDI-Public: (01)00801741121319
• 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): 01/22/2020

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: VA8074
• Device Catalogue Number: VA8074
• Device Lot Number: 93SD0072
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 01/22/2020
• Patient Sequence Number: 1