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

Catalog Number	R51008004L
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, an 8mm 4cm saberx radianz percutaneous transluminal angioplasty (pta) balloon was used.However, when the doctor attached the indeflator device and applied negative pressure, air was aspirated out from somewhere.The physician tried attaching a three-way stopcock and it was properly connected to the indeflator, but s/he could still hear a hissing sound of air being aspirated in from somewhere.The malfunction was noted to have occurred during inflation.The procedure was completed with a same size non-cordis balloon catheter.There was no reported injury to the patient.The product was stored properly according to the instructions for use.There was no difficulty removing the product from the hoop, removing the protective balloon cover, stylet, or any of the sterile packaging components.There are no kinks or other damages noted prior to inserting the device into the patient.The intended procedure was from the radial artery to the iliac.The lesion had mild calcification with mild vessel tortuosity.The lesion was noted to have an 80% stenosis.The device was not being used to treat a chronic total occlusion (cto).The same inflation device was used with other devices during the procedure.There was no resistance/ friction while inserting the balloon through the rotating hemostatic valve.There was no resistance/ friction while inserting the balloon catheter through the guide catheter.There was no difficulty advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion.The catheter was never in an acute bend and was not kinked during use.The device will be returned for evaluation.
Additional Manufacturer Narrative
This event no longer meets the definition of a malfunction that requires submission of a regulatory report.No additional reports will be forthcoming.This case is no longer considered reportable.Malfunction code of balloon-leakage no longer applies.
Event or Problem Description
As reported, an 8mm 4cm saberx radianz percutaneous transluminal angioplasty (pta) balloon was used.However, when the doctor attached the indeflator device and applied negative pressure, air was aspirated out from somewhere.The product evaluation confirmed the luer hub was cracked.The physician tried attaching a three-way stopcock and it was properly connected to the indeflator, but s/he could still hear a hissing sound of air being aspirated in from somewhere.The malfunction was noted to have occurred during inflation.The procedure was completed with a same size non-cordis balloon catheter.There was no reported injury to the patient.The product was stored properly according to the instructions for use.There was no difficulty removing the product from the hoop, removing the protective balloon cover, stylet, or any of the sterile packaging components.There are no kinks or other damages noted prior to inserting the device into the patient.The intended procedure was from the radial artery to the iliac.The lesion had mild calcification with mild vessel tortuosity.The lesion was noted to have an 80% stenosis.The device was not being used to treat a chronic total occlusion (cto).The same inflation device was used with other devices during the procedure.There was no resistance/ friction while inserting the balloon through the rotating hemostatic valve.There was no resistance/ friction while inserting the balloon catheter through the guide catheter.There was no difficulty advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion.The catheter was never in an acute bend and was not kinked during use.The device will be returned for evaluation.

• Brand Name: SABERX RADIANZ
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes FL 33014
• 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: 20029784
• Report Number: 3007635982-2024-00207
• Device Sequence Number: 8600706
• Product Code: LIT
• UDI-Device Identifier: 20705032081471
• UDI-Public: (01)20705032081471(17)270131(10)82303893
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2024

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
• Device Catalogue Number: R51008004L
• Device Lot Number: 82303893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/11/2024
• Date Device Manufactured: 02/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown