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

Model Number	DR13554
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
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 returned for the evaluation.On the visual evaluation the catheter appeared to have the blood residue and no other anomalies were noted.On the functional evaluation, the guide wire lumen was flushed using an in-house syringe and next to that in-house guide wire has been inserted through the distal tip and exited without any issue.On further the balloon was inflated with an in-house presto inflation device, while inflation the water leaked out from the balloon at the glue joint.Under the microscopic evaluation of the balloon the circumferential break was observed at the proximal glue joint.Therefore the investigation for the reported leak and identified break has been confirmed because while inflating the balloon using an in-house presto inflation device, water leaked from the break at the glue joint.The device glue joint break most likely is the root cause of the device leak.However, the definitive root cause of the identified device joint break and leak 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.(expiry date: 08/2023).
Event or Problem Description
It was reported that during an angioplasty procedure, the inflation device allegedly leaked at the point by the guidewire light during inflation.It was further reported that another device was used to complete the procedure.There was no reported patient injury.

• 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: 11846866
• Report Number: 2020394-2021-01062
• Device Sequence Number: 3766658
• Product Code: LIT
• UDI-Device Identifier: 00801741058516
• UDI-Public: (01)00801741058516
• 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): 04/29/2021

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: DR13554
• Device Catalogue Number: DR13554
• Device Lot Number: 93VE0012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other