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

Model Number	DR135510
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes one malfunction event.A review of the event indicated that model dr135510 pta balloon dilatation catheter allegedly ruptured.These report was received from various source.Of the one event, did involved patients with no reported patient injury.The patients age, weight and gender not provided.
Additional Manufacturer Narrative
For the reported event, the sample was returned for evaluation, lot number was provided, lot history review.The complaint was reassessed for reportability and determined to be not reportable as it was reported that the pta balloon ruptured, with no detached material, vessel damage, or retraction issues.After inflation of the balloon, no water was observed exiting the balloon and the balloon was deflated without issue.Therefore, the result of the investigation is unconfirmed for the alleged balloon rupture as the alleged event could not be replicated.Evaluation of the device did not observe any contributing factors that would have caused the alleged event.The definitive root cause for the reported balloon rupture could not be determined based upon available information.The device was labeled for single use.
Event or Problem Description
This report summarizes one malfunction event.A review of the event indicated that model dr135510 pta balloon dilatation catheter allegedly ruptured.These report was received from various source.Of the one event, did involved patients with no reported patient injury.The patient is 55 years of age, the gender is female, and the weight is (b)(6).

• 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: 8519702
• Report Number: 2020394-2019-00344
• Device Sequence Number: 11242786
• Product Code: LIT
• 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
• Report Date (Section B): 07/25/2019

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: DR135510
• Device Catalogue Number: DR135510
• Device Lot Number: 93ZB0156
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 07/25/2019
• Patient Sequence Number: 1