MAUDE Adverse Event Report: CORDIS US. CORP SABERX RADIANZ; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number R51002002L

Device Problem Material Puncture/Hole (1504)

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

Event Date 08/17/2023

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82258880 presented no issues during the manufacturing process that can be related to the reported event.This device has been analyzed but the final, approved draft of the engineering report and its conclusion is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.H3 other text : this device has been analyzed but the final, approved draft of the engineering report and its conclusion is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

As reported, during the rated balloon pressure (rbp) testing of two 2mm x 2cm 190cm saberx radianz percutaneous transluminal angioplasty (pta) balloon catheters, the balloons did not burst, and the inflation liquid leaked from the rapid exchange (rx) ports on each device.The devices were not used on a patient.The rx ports were not flushed prior to rbp testing.Negative pressure was able to be applied to both devices.An unknown inflation device filled with water was used to inflate the balloons of both devices.The first device was inflated to 30 atmospheres (atm) when the leakage occurred.The second device was inflated to 32 atm when the leakage occurred.Both balloons were fully expanded during their inflations.There were no observed deflation difficulties with either device.The devices have now been returned.Addendum: product evaluation revealed multiple punctures on the body/shaft of the first 2mm x 2cm 190cm saberx radianz pta balloon catheter.

• Brand Name: SABERX RADIANZ
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; coyol free zone, building b25, , , costa rica; el coyol alajuela bld 25 ; 7863138372
• MDR Report Key: 18649821
• MDR Text Key: 336064202
• Report Number: 3007635982-2024-00025
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: R51002002L
• Device Lot Number: 82258880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2022
• 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: UNKNOWN CATHETER