MAUDE Adverse Event Report: CORDIS CORPORATION BLUE/AVIATOR/PLUS 5X12/142P PK; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number PB1250PPX

Device Problem Leak/Splash (1354)

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

Event Date 11/22/2021

Event Type  malfunction  

Event Description

As reported , a blue/aviator/plus 5x12/142p pk was used and the balloon leaked.The damage was noted to the balloon, before being inserting patient and during flushing of the device.There was no reported patient injury.The device was not used in the patient.There were no anomalies noted when the device was taken out of the package during or after the device was prepped.The device was not resterilized.The device was pulled from the packaging by the hub and no anomalies were noted at this time.The device was prepped following ifu instructions.There was no difficulty encountered connecting the hub to the indeflator device.A non -cordis indeflator device was used.The device will be returned for evaluation.

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot# 82214941 presented no issues during the manufacturing process that can be related to the reported complaint.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Manufacturer Narrative

A blue/aviator/plus 5x12/142p stent delivery system (sds) was used and the balloon leaked.The damage was noted to the balloon, before being inserting patient and during flushing of the device.There was no reported patient injury.The device was not used in the patient.There were no anomalies noted when the device was taken out of the package during or after the device was prepped.The device was not resterilized.The device was pulled from the packaging by the hub and no anomalies were noted at this time.The device was prepped following ifu (instructions for use).There was no difficulty encountered connecting the hub to the indeflator device.A non-cordis indeflator device was used.The product was returned for analysis.One non-sterile blue/aviator/plus 5x12/142psds was received for analysis coiled inside a plastic bag.Per visual analysis the aviator plus balloon was received with the palmaz blue stent mounted on.The stent was observed properly affixed to the balloon, not expanded.No other anomalies found.Per functional analysis a lab sample syringe filled with water was used to perform the guide wire lumen flushing test.The guide wire lumen flushing test was successfully performed.Then, a lab sample inflator/ deflator device partially filled with water was attached to the inflation lumen of the sds and pressure was applied.The balloon was successfully inflated, and the stent was completely expanded as expected.No anomalies were observed neither on the aviator plus balloon nor on the palmaz blue expandable stent.A product history record (phr) review of lot 82214941 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst-at/below rbp¿ was not confirmed by analysis of the returned device as functional analysis was performed successfully.The exact cause of the reported event could not be determined.According to the precautions in the safety information in the instructions for use ¿prior to use, the product should be examined to verify functionality and integrity.¿ the device performed as intended and therefore the reported event could not be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time at this time.

• Brand Name: BLUE/AVIATOR/PLUS 5X12/142P PK
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13018944
• MDR Text Key: 290084112
• Report Number: 9616099-2021-05201
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20705032062036
• UDI-Public: (01)20705032062036(17)210131(10)82214941
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: PB1250PPX
• Device Catalogue Number: PB1250PPX
• Device Lot Number: 82214941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2021
• 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
• Treatment: MERIT PRESSURE PUMP
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 87 KG