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

Model Number	US35130510
Medical Device Problem Codes	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
As the lot number for the device was provided, a manufacturing review was performed.The sample was returned to the manufacturer for inspection/evaluation.Therefore, the investigation is confirmed for the reported balloon rupture, detachment and retraction problem.Based on the available information, the definitive root cause for this event is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates that model us35130510 pta balloon dilatation catheter allegedly experienced retraction problem, material rupture and detachment of device.The information was received from a single source.One patient was involved with no reported patient injury.A (b)(6) female patient's weight was not provided.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a lot history review was performed.The sample was returned to the manufacturer for inspection/evaluation.The investigation was confirmed for hub detachment, retraction issue as the device was returned stuck in the sheath and inconclusive for the balloon rupture.Based on the available information, the definitive root cause for this malfunction was unknown.The device was labeled for single use.H10: g4.H11: g7, h2, h6 (results).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 indicates that model us35130510 pta balloon dilatation catheter allegedly experienced retraction problem, material rupture and detachment of device.The information was received from a single source.One patient was involved with no reported patient injury.A 60 years old female patient's weight was not provided.

• Brand Name: ULTRASCORE FOCUSED FORCE PTA BALLOON
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10293436
• Report Number: 2020394-2020-04647
• Device Sequence Number: 2526523
• Product Code: PNO
• UDI-Device Identifier: 00801741116773
• UDI-Public: (01)00801741116773
• 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): 10/21/2020

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: US35130510
• Device Catalogue Number: US35130510
• Device Lot Number: GFDR1979
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 07/18/2020
• Supplement Report FDA Received Date: 10/21/2020
• Patient Sequence Number: 1