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

Model Number DR8084

Device Problem Packaging Problem (3007)

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

Event Date 07/09/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the physical device was not returned for evaluation.Two electronic photos were reviewed.The first photo shows the shipping carton which appears to be bent and damaged at its midsection.The second photo shows the outer packaging box of the dorado pta balloon dilatation catheter.The midsection of the packaging box appears to be crushed and bent.No evidence of sterile breach noted on the device.Therefore, based on the photo review, the reported packaging problem can be confirmed as the boxes appear to be damaged and bent.A definitive root cause for the alleged packaging problem 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.

Event Description

It was reported that prior to an angioplasty procedure, the package of the device was allegedly damaged.There was no patient contact.

• Brand Name: DORADO
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): FUTUREMATRIX INTERVENTIONAL; 1605 enterprise street; athens 75751
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12728550
• MDR Text Key: 279334676
• Report Number: 2020394-2021-01928
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741059254
• UDI-Public: (01)00801741059254
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072283
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DR8084
• Device Catalogue Number: DR8084
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1