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

Model Number	DR13568
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was returned for evaluation.The sample was appeared to be clean.No kinks or anomalies to the luers, bifurcate or glue fillets.Peeled pebax was noted to the balloon approx.9.3cm from the distal tip.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 dr13568 pta balloon dilatation catheter allegedly experienced delamination and a material rupture.This information was received from a single source.The alleged malfunction involved a patient with no known impact to the patient.The patient was reported to be (b)(6), weight and gender were not provided.
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 investigation is confirmed for peeling and material rupture.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 dr13568 pta balloon dilatation catheter allegedly experienced delamination and a material rupture.This information was received from a single source.The alleged malfunction involved a patient with no known impact to the patient.The patient was reported to be 74-years-old, weight and gender were not provided.

• 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: 8811695
• Report Number: 2020394-2019-01652
• Device Sequence Number: 2417363
• Product Code: LIT
• UDI-Device Identifier: 00801741064159
• UDI-Public: (01)00801741064159
• 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): 10/18/2019

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: DR13568
• Device Catalogue Number: DR13568
• Device Lot Number: 93VC0075
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 10/18/2019
• Patient Sequence Number: 1