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

Model Number	DR13564
Medical Device Problem Codes	Break (1069); Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 dilatation catheter has been received for the evaluation.On the visual evaluation, the device was noted bloody.No other specific anomalies were noted.On the functional evaluation, the balloon was inflated using an in-house presto inflation device and water was noted to be leaking from the distal tip.The device was examined under the microscopic observation and a circumferential break was noted at the glue joint.Then the balloon was cut and noted a hole at the proximal end of the guidewire lumen.No other functional testing performed.Therefore the investigation for the reported leak was confirmed as the water starts leaking from the circumferential break at proximal glue joint of the balloon upon inflation.The investigation for identified break was confirmed as the circumferential break was noted at proximal glue joint of the balloon under the microscopic observation.The investigation for the identified guidewire lumen hole was confirmed as the hole was noted at the inner guidewire lumen at proximal end of the balloon under the microscopic observation.The identified break at proximal glue joint of the balloon and the guidewire lumen hole are likely the root cause for the reported leak.However a definitive root cause for the reported leak and the identified break, guidewire lumen hole could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.(expiry date: 11/2023).
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly leaked at the proximal end.There was no reported patient injury.

• Brand Name: DORADO
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 12486076
• Report Number: 2020394-2021-01717
• Device Sequence Number: 4030209
• Product Code: LIT
• UDI-Device Identifier: 00801741058745
• UDI-Public: (01)00801741058745
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072283
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/23/2021

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: DR13564
• Device Catalogue Number: DR13564
• Device Lot Number: 93YE0093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2021
• Initial Report FDA Received Date: 09/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1