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

Model Number	US14150320
Medical Device Problem Codes	Break (1069); Deflation Problem (1149); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The one device belonging to the sole malfunction is expected to be 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 us14150320 pta balloon dilatation catheter allegedly experienced deflation issue and detachment of device or device component.This information was received from a single source.The malfunction involved a patient with no reported consequence.The patient was reported as a (b)(6) year-old male weighing (b)(6) kgs.
Additional Manufacturer Narrative
H10: the sample was returned for evaluation.The lot number was provided and a lot history review will be performed.The company is still investigating the issue at this time.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 information indicated that model us14150320 pta balloon dilatation catheter allegedly experienced deflation issue and detachment of device or device component.This information was received from a single source.The malfunction involved a patient with no reported consequence.The patient was reported as a 72-year-old male weighing 90 kgs.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model us14150320 pta balloon dilatation catheter allegedly experienced deflation issue and detachment of device or device component.This information was received from a single source.The malfunction involved a patient with no reported consequence.The patient was reported as a 72-year-old male weighing 90 kgs.
Additional Manufacturer Narrative
H10: the lot number was provided and a lot history review was performed.The sample was returned for evaluation.The investigation is confirmed for the distal tip tear, as a tear was noted to the distal tip.Also, the investigation is unconfirmed for the reported deflation issue, as the balloon was inflated and deflated without any issues during evaluation.The definitive root cause for the reported deflation issue, distal tip tear and wire break could not be determined based upon available information.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.

• 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: 9587609
• Report Number: 2020394-2020-00232
• Device Sequence Number: 16964650
• Product Code: PNO
• UDI-Device Identifier: 00801741113536
• UDI-Public: (01)00801741113536
• 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,Followup
• Report Date (Section B): 06/26/2020

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: US14150320
• Device Catalogue Number: US14150320
• Device Lot Number: GFDU2030
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 03/25/2020; 06/24/2020
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 04/01/2020; 06/26/2020
• Patient Sequence Number: 1