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

Catalog Number	48008010X
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the 8mm10cm saber percutaneous transluminal angioplasty (pta) balloon leaked contrast agent as the pressure pump filled the balloon to dilate the lesion.The balloon was inflated one time prior to the leak.Resistance/ friction was noted while inserting the balloon catheter through the rotating hemostatic valve and while inserting the balloon through the guide catheter.There was difficulty advancing the balloon catheter through the vessel.There was also a difficulty noted while crossing the legion with the balloon catheter.The device was removed intact from the patient.The procedure was completed with the use of a non-cordis balloon.There was no reported injury to the patient.The device 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 were no kinks or other damages noted prior to inserting the device into the patient.The device was prepped per the ifu and was able to maintain negative pressure.The lesion was noted to have moderate calcification.The vessel was noted to have moderate tortuosity.The lesion had a 50% stenosis.The device was not being used to treat a chronic total occlusion (cto).The catheter was never in an acute bend and was not kinked during use.The contrast to saline ratio was 1:1.The device will be returned for evaluation.
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, the 8mm10cm saber percutaneous transluminal angioplasty (pta) balloon luer hub leaked contrast agent as the pressure pump filled the balloon to dilate the lesion.The balloon was inflated one time prior to the leak.Resistance/ friction was noted while inserting the balloon catheter through the rotating hemostatic valve and while inserting the balloon through the guide catheter.There was difficulty advancing the balloon catheter through the vessel.There was also a difficulty noted while crossing the legion with the balloon catheter.The device was removed intact from the patient.The procedure was completed with the use of a non-cordis balloon.There was no reported injury to the patient.The device 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 were no kinks or other damages noted prior to inserting the device into the patient.The device was prepped per the ifu and was able to maintain negative pressure.The lesion was noted to have moderate calcification.The vessel was noted to have moderate tortuosity.The lesion had a 50% stenosis.The device was not being used to treat a chronic total occlusion (cto).The catheter was never in an acute bend and was not kinked during use.The contrast to saline ratio was 1:1.The device will be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b5.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.

• Brand Name: SABER
• 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: 20030616
• Report Number: 3007635982-2024-00208
• Device Sequence Number: 7363765
• Product Code: LIT
• UDI-Device Identifier: 20705032069745
• UDI-Public: (01)20705032069745(17)270331(10)82308127
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K971010
• 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): 08/22/2024

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: 48008010X
• Device Lot Number: 82308127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2024
• 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: 08/22/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 08/22/2024
• Date Device Manufactured: 04/03/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TERUMO V18 GUIDEWIRE; UNK CORDIS CATHETER
• Patient Sex: Unknown