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

Model Number	VA80104
Medical Device Problem Codes	Deflation Problem (1149); Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided; therefore, a lot history review was performed.For the two malfunctions samples were returned, and the investigation is confirmed for the reported deflation problem and retraction problem.A definite root cause for the reported event could not be determined.The device was labeled for single use.
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicated that model va80104 pta balloon dilatation catheter allegedly experienced deflation problem and retraction problem.This information was received from one source.This malfunction involved one patient with no consequences.The weight of (b)(6) year old male is (b)(6) pounds.
Additional Manufacturer Narrative
H10: the lot number was provided; therefore, a lot history review was performed.For the two malfunctions samples were returned, and the investigation is confirmed for the reported retraction problem and inconclusive for the reported deflation problem.A definite root cause for the reported event could not be determined.The device was 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 malfunctions.A review of the reported information indicated that model va80104 pta balloon dilatation catheter allegedly experienced deflation problem and retraction problem.This information was received from one source.This malfunction involved one patient with no consequences.The weight of 64 year old male is 170 pounds.

• 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: 10308244
• Report Number: 2020394-2020-04897
• Device Sequence Number: 16986975
• Product Code: DQY
• UDI-Device Identifier: 00801741121258
• UDI-Public: (01)00801741121258
• 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): 10/27/2020

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: VA80104
• Device Catalogue Number: VA80104
• Device Lot Number: 93NE0032
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 10/27/2020
• Patient Sequence Number: 1