MAUDE Adverse Event Report: CORDIS CORPORATION SABER 6MM25CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	48006025X
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during preparation of a 6mm x 25cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter, it was not possible to flush the device and it was reported that the device appeared kinked.As a result, the device was not used in the patient, and a 6mm x 25cm.018 saber pta balloon catheter was used without issue to complete the procedure.There was no reported injury to the patient.It was reported that the damage was observed after the device was removed from its sterile packaging.There was no difficulty removing the device from its packaging and the device was stored per the instructions for use (ifu).The device will be returned for evaluation.Addendum: product evaluation revealed an adhesive plug obstructing the guidewire lumen of the saber pta balloon catheter.
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.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
Complaint conclusion: as reported, during preparation of a 6mm x 25cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter, it was not possible to flush the device and it was reported that the device appeared kinked.As a result, the device was not used in the patient, and a 6mm x 25cm.018 saber pta balloon catheter was used without issue to complete the procedure.There was no reported injury to the patient.It was reported that the damage was observed after the device was removed from its sterile packaging.There was no difficulty removing the device from its packaging and the device was stored per the instructions for use (ifu).The device was returned for analysis.A non-sterile saber 6mm x 25cm 150 was received coiled inside of a clear plastic bag.The device was unpacked to proceed with the product evaluation.The unit was thoroughly inspected observing that the device does not present any damages or anomalies.The balloon was received not inflated.Functional test was performed, the flushing process was attempted to be performed, a syringe full of water was attached to the guidewire lumen port.Then positive pressure was applied to flush the device.The water did not flow through the part due to an obstruction in the guidewire lumen.A lab sample guidewire of the appropriate size was inserted via the distal tip to determine if any resistance/friction or obstruction is observed.The guidewire traveled inside of the guidewire lumen until it reached the obstruction approximately 22mm from the proximal end and could not advance further.The lab sample was inserted this time by the guidewire port.The guidewire traveled inside of the guidewire lumen by approximately 19 cm from the proximal end until the obstruction was reached and could not advance further.One inflator/deflator device was attached to the inflation port.Balloon inflation testing was done by applying positive pressure using the inflator/deflator device with the purpose of reach the rate burst pressure.The balloon was inflated as expected and the pressure remained steady.No anomalies were observed.The area where the obstruction is located was inspected with a vision system to obtain a magnified image.An obstruction of approximately 2mm was observed inside of the guidewire lumen.A cross-section cut where the obstruction is located was made to determine what is causing the obstruction finding a tiny plug tucked inside the guidewire lumen.The plug was analyzed by ft-ir analysis.For this analysis, the sample was first viewed through vision system.The sample was directly analyzed by ft-ir equipment without any additional preparation.The infrared spectra showed some peaks that could be related to some adhesive as they contain c=o and c-o-c groups.A comparison was performed with an adhesive ¿dymax¿.There are similarities between the comparison performed as the spectra showed similar peaks related to adhesives.In conclusion: it is suggested that the plug obstructing the guidewire lumen shares functional groups characteristic of an adhesive.A product history record (phr) review of lot 82246663 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 kinked/bent - during prep¿ was not confirmed as no kinks or anomalies were noted on the device.However, ¿guidewire lumen obstructed¿ was confirmed via device analysis.The exact cause cannot be determined.During ft-ir analysis the material noted inside the guidewire lumen was noted to have characteristics of an adhesive similar to dymax.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 needs further investigation to determine root cause.Therefore, an investigation has been initiated.

• Brand Name: SABER 6MM25CM 150
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• 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: 16091137
• Report Number: 9616099-2023-06202
• Device Sequence Number: 6686415
• Product Code: LIT
• UDI-Device Identifier: 20705032069646
• UDI-Public: (01)20705032069646(17)250430(10)82246663
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): N
• 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): 02/03/2023

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: 04/30/2025
• Device Model Number: 48006025X
• Device Catalogue Number: 48006025X
• Device Lot Number: 82246663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2022
• Supplement Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2022
• 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: 6MM X 25CM .018 SABER PTA BALLOON CATHETER
• Patient Sex: Unknown