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

Model Number DR4064

Device Problems Break (1069); Peeled/Delaminated (1454); Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2020

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.However, an image was provided for review.The investigation of the reported event is currently underway.(expiry date: 03/2023).

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured at 24 atm on the third inflation attempt.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one dorado pta catheter has returned for evaluation.On the visual evaluation of the device it appeared bloody.Peeled pebax has noted on the balloon.No other specific anomalies noted on the device.On the functional evaluation of the device the guidewire has flushed and an in-house guide-wire has inserted through the device without any issue.On further the balloon inflated with in-house presto inflation device.On inflating the balloon at 8 atm, the balloon inflated uniformly, no leaks no rupture noted and maintained the pressure.Then the balloon tried to inflate to 24 atm, on reaching 20 atm.Water leaks noted at the glue joint at the proximal end of the balloon.Under microscopic examination it has noted a circumferential break noted at the proximal joint, then the balloon deflated without any issue.Therefore, the reported balloon rupture was unconfirmed as no rupture was noted to the inflated balloon and it deflated without any issues.However, the investigation is confirmed for the identified break as water leak was noted at the glue joint of the balloon.The investigation is also confirmed for peeled pebax, as balloon was noted to have pebax deformation during visual evaluation.A image reviewed and it shows very low quality image from a procedure of the forearm without a date provided.This image show a balloon catheter over a wire that has a balloon that is fully inflated without rupture demonstrated.Based on the submitted image, the reported balloon rupture can not be confirmed.A definitive root cause for the balloon rupture, peeled pebax and glue joint break could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: (expiry date: 03/2023).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 Description

It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured at 24 atm on the third inflation attempt.There was no reported patient injury.

• 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: 10874554
• MDR Text Key: 217455167
• Report Number: 2020394-2020-20528
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741058714
• UDI-Public: (01)00801741058714
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DR4064
• Device Catalogue Number: DR4064
• Device Lot Number: 93QE0033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Date Manufacturer Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other