MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. TRUE DILATATION BALLOON VALVULOPLASTY CATHETERS; VALVULOPLASTY BALLOON

Model Number	0184511
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review was performed.The device has been returned for evaluation; the evaluation identified material puncture.Based upon the available information, 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 information indicated that model 184511 valvuloplasty balloon allegedly experienced a material puncture.This information was received from a single source.There was no reported patient involvement for the malfunction.The patient¿s age, weight, and sex were not reported.
Additional Manufacturer Narrative
H10: the lot number for the malfunction was provided and a lot history review was performed.The device has been returned for evaluation; the evaluation identified material split.Based upon the available information, 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 information indicated that model 184511 valvuloplasty balloon allegedly experienced a material split.This information was received from a single source.There was no reported patient involvement for the malfunction.The patient¿s age, weight, and sex were not reported.

• Brand Name: TRUE DILATATION BALLOON VALVULOPLASTY CATHETERS
• Common Device Name: VALVULOPLASTY BALLOON
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8809534
• Report Number: 2020394-2019-01636
• Device Sequence Number: 326702
• Product Code: OZT
• UDI-Device Identifier: 00801741097430
• UDI-Public: (01)00801741097430
• 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): 01/17/2020

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: 0184511
• Device Catalogue Number: 0184511
• Device Lot Number: GFDP0750
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 07/19/2019
• Supplement Report FDA Received Date: 01/17/2020
• Patient Sequence Number: 1