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

Model Number	US35130515
Medical Device Problem Codes	Break (1069); Retraction Problem (1536); 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 lot number was not provided; therefore, a lot history review was not performed.The device was returned to the manufacturer for evaluation.Therefore the investigation is confirmed for the reported retraction issue and catheter break issue.The definitive root cause is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported malfunction indicated that model us35130515 pta balloon dilatation catheter allegedly had a retraction issue and break.This report was received from one source.One patient was involved with no reported patient injury.The male patient is (b)(6).Weight of the patient was not provided.
Additional Manufacturer Narrative
H10: the lot number was not provided; therefore, a lot history review was not performed.The device was returned to the manufacturer for evaluation.Therefore the investigation is confirmed for the reported retraction issue and hub detachment issue.The definitive root cause is unknown.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 malfunction indicated that model us35130515 pta balloon dilatation catheter allegedly had a retraction issue and break.This report was received from one source.One patient was involved with no reported patient injury.The male patient is 70 years old.Weight of the patient 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: 10293433
• Report Number: 2020394-2020-04644
• Device Sequence Number: 14084984
• Product Code: PNO
• UDI-Device Identifier: 00801741116797
• UDI-Public: (01)00801741116797
• 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: US35130515
• Device Catalogue Number: US35130515
• Device Lot Number: UNKNOWN
• 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