MAUDE Adverse Event Report: CORDIS US. CORP SABER 3MM30CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	48003030X
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, soon as the saber 3mm 30cm balloon was removed from the packaging there was a defect noted because there was no progression of saline solution in the attempt to wash the catheter.Additionally, there was no progression of the guidewire.It was internally blocked.The case was completed with the use of another unknown wire and balloon catheter.There was no reported injury to the patient.Additional information was requested; however, the information was not obtained after multiple attempts made.The device was returned for analysis.A non-sterile saber 3mm x 30cm 150 percutaneous transluminal angioplasty (pta) balloon catheter was received for analysis coiled inside a plastic bag.Per visual analysis, no anomalies were detected on the saber by the naked eye.Neither compressed nor flattened sections on the body shaft, nor crystallized contrast medium in the guidewire lumen were observed.Guidewire lumen flushing was intended to be performed; however, flushing could not be achieved.Then, a guide wire insertion test was intent to be performed.An appropriate.018¿ lab sample guidewire was inserted via hub with unsuccessful results.The guidewire could not pass entirely through the guidewire lumen of the unit.The guidewire was advanced and stopped at 116.3cm from the hub and no longer advanced.An obstruction was felt at this point.Per microscopic analysis, the guidewire lumen of the unit was cross sectioned at the obstructed area and a piece of inner body polyethylene was tucked inside the guidewire lumen.The polyethylene material was observed accordioned (zigzag) inside the guidewire lumen.Additionally, the piece of inner body polyethylene looks ripped at the separated area.Per dimensional analysis, the accordioned polyethylene material was taken out for measurement from the guidewire inner body.The polyethylene was found still attached to the unit at the proximal hub area.The polyethylene material unraveled and measured 9mm in length.A product history record (phr) review of lot 82239680 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿pta/ptca system flushing difficulty - during prep¿ and ¿guidewire lumen obstructed- during prep¿ was confirmed via device analysis.However, the exact cause cannot be determined.During analysis the material noted inside the guidewire lumen was noted to be polyethylene, the same material that is comprised of the guidewire lumen inner body.It is likely the accordioned piece was sheared off at some point due to the interaction of the lining with a sharp object.Several factors are being considered and further investigation is required to find a definitive root cause.Therefore, based on the information available for review, it is difficult to draw a clinical conclusion between the device and the events reported as further investigation is warranted.According to the warnings in the safety information in the instructions for use, ¿flush all devices entering the vascular system with sterile heparinized saline or similar isotonic solution.Prior to use, ensure all devices have been flushed and air is removed from the system according to standard medical practice.Failure to do so could result in air entering the vascular system.¿ the phr review does not suggest a manufacturing related issue; however, product analysis suggests that the event experienced by the customer needs further investigation to determine root cause.Therefore, an investigation has been initiated.
Event or Problem Description
As reported, soon as the saber 3mm 30cm balloon was removed from the packaging, there was a defect noted because there was no progression of saline solution in the attempt to wash the catheter and also no progression of the guide wire.It was internally blocked.The case was completed with the use of another unknown wire and balloon catheter.There was no reported injury to the patient.Additional information was requested; however, the information was not obtained after multiple attempts made.The device was returned for evaluation.

• Brand Name: SABER 3MM30CM 150
• 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 ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 16396714
• Report Number: 9616099-2023-06262
• Device Sequence Number: 5685866
• Product Code: LIT
• UDI-Device Identifier: 20705032069134
• UDI-Public: (01)20705032069134(17)241231(10)82239680
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K971010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/17/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: 48003030X
• Device Catalogue Number: 48003030X
• Device Lot Number: 82239680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2022
• 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: UNK BALLOON CATHETER; UNK GUIDEWIRE; UNK WIRE
• Patient Sex: Unknown