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

Model Number	VA8084
Medical Device Problem Code	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 for one of the three malfunctions was provided and a lot history review was performed.One of the three devices were returned to bd for evaluation.Two of the investigation were inconclusive for the reported retraction issues since no sample was returned and no objective evidence was provided.The remaining investigation is still underway.The company is still investigating the issue at this time.The devices are labeled for single use.
Event or Problem Description
This report summarizes three malfunctions.A review of the reported information indicated that model va8084 pta balloon dilatation catheter allegedly experienced retraction problem.This information was received from various sources.The three malfunctions involved a patient with no consequences.One patient was a (b)(6) year old female that weighed (b)(6) pounds.The remaining patient age, weight, and gender were not provided.
Additional Manufacturer Narrative
H10: for the three reported complaints, one device was returned for evaluation.Lot numbers were provided for one out of the three malfunctions; therefore, a lot history review was performed.For the one device that was returned, investigation for retraction issue was inconclusive, however investigation confirmed for balloon rupture and detachment.For the remaining 2 malfunctions, the devices were not returned, therefore the investigation is inconclusive.The definitive root cause is unknown.The device was labeled for single use.H11: g1, 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.
Event or Problem Description
This report summarizes three malfunctions.A review of the reported information indicated that model va8084 pta balloon dilatation catheter allegedly experienced retraction problem.This information was received from various sources.The three malfunctions involved a patient with no consequences.One patient was a 70 year old female that weighed 204 pounds.The remaining patient age, weight, and gender were not provided.

• 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: 9979804
• Report Number: 2020394-2020-03086
• Device Sequence Number: 2168265
• Product Code: DQY
• UDI-Device Identifier: 00801741121333
• UDI-Public: (01)00801741121333
• 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): 07/13/2020

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: VA8084
• Device Catalogue Number: VA8084
• Device Lot Number: 93XD0012, UNKNOWN
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 04/20/2020
• Supplement Report FDA Received Date: 07/13/2020
• Patient Sequence Number: 1