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

Model Number DR8064

Device Problems Break (1069); Material Puncture/Hole (1504); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2018

Event Type  malfunction  

Manufacturer Narrative

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.Expiry date: 04/2021.

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured.Another device was used to complete the procedure.There was no reported patient injury.

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured.Another device was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

H10: 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.An inflation attempt was made and water was noted exiting the balloon in two locations near the distal cone.The fibers were stripped from the balloon and a partial circumferential rupture was noted in the barrel of the balloon.Additionally, a crack/hole in the balloon material was noted where the balloon bonds to the distal tip.Therefore, the investigation is confirmed for a circumferential rupture, and for a hole in the balloon material.The definitive root cause for the circumferential rupture or the hole in the balloon material could not be determined based upon the 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.H10: d4 (expiry date: 04/2021).H11: h3, h6 (patient code: remove 1069 - break).

• Brand Name: DORADO PTA DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8340201
• MDR Text Key: 136190129
• Report Number: 2020394-2019-00127
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741058721
• UDI-Public: (01)00801741058721
• Combination Product (y/n): N
• PMA/PMN Number: K072283
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/10/2019

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
• Device Operator: Health Professional
• Device Model Number: DR8064
• Device Catalogue Number: DR8064
• Device Lot Number: 93YC0068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Initial Date Manufacturer Received: 01/22/2019
• Initial Date FDA Received: 02/14/2019
• Supplement Dates Manufacturer Received: 05/08/2019
• Supplement Dates FDA Received: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Weight: 68