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

Model Number	DR80510
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that during an angioplasty procedure an alleged leak was found in the catheter shaft of the pta balloon during the first inflation attempt.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure an alleged leak was found in the catheter shaft of the pta balloon during the first inflation attempt.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was returned for evaluation.The device was inflated with water, and a leak was identified at the proximal balloon butt joint.Upon closer examination, a partial break at the butt joint was identified, resulting in the leak.Therefore, the investigation is confirmed for the reported leak, as well as for a break at the butt joint.The partial break at the glue butt joint resulted in the identified leak.However, the definitive root cause for the partial break could not be determined based upon available information.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.

• 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: 8118524
• Report Number: 2020394-2018-02137
• Device Sequence Number: 19253120
• Product Code: DQY
• UDI-Device Identifier: 00801741058578
• UDI-Public: (01)00801741058578
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K072283
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2019

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: Health Professional
• Device Model Number: DR80510
• Device Catalogue Number: DR80510
• Device Lot Number: 93YB0069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Initial Date Received by Manufacturer: 11/05/2018
• Supplement Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 04/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR