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

Model Number	DR135510
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.The company is still investigating the issue currently.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 dr135510 pta balloon dilatation catheter allegedly broke after one inflation.One patient was involved and there was no reported patient injury.This information was received from one source.Patient was a (b)(6) female, weighing (b)(6).
Additional Manufacturer Narrative
H10: the device was returned to bd for evaluation.The investigation was identified for break.Based on the information provided, the definitive root cause is unknown.The device is labeled for single use.H11: b5, 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 one malfunction.A review of the reported information indicated that model dr135510 pta balloon dilatation catheter allegedly broke after one inflation.This information was received from one source.One patient was involved and there was no reported patient injury.Patient was a 98 year old female, weighing 50 kgs.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model dr135510 pta balloon dilatation catheter allegedly broke after one inflation.This information was received from one source.One patient was involved and there was no reported patient injury.Patient was a 98 year old female, weighing 50 kgs.
Additional Manufacturer Narrative
H10: tthe lot number for the malfunction was provided and a lot history review was performed.The device was returned to bd for evaluation and trending device code has been updated ( 1069 - break, 2923 - dislodgement, 2923h - marker bands, 2976 - material deformation).The investigation was identified for break.Based on the information provided, 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.

• Brand Name: DORADO 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: 8812360
• Report Number: 2020394-2019-01662
• Device Sequence Number: 2418034
• Product Code: DQY
• UDI-Device Identifier: 00801741058592
• UDI-Public: (01)00801741058592
• 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): 01/07/2020

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: DR135510
• Device Catalogue Number: DR135510
• Device Lot Number: 93WC0112
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019; 12/31/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 10/14/2019; 01/07/2020
• Patient Sequence Number: 1