MAUDE Adverse Event Report: CORDIS CORPORATION SABER 6MM15CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	48006015X
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, after the successful inflation of a 6mm x 15cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter, the device became stuck inside of an unknown catheter sheath introducer (csi) and was unbale to be removed.It was reported that everything had to be removed, including the unknown csi, in order to remove the saber pta balloon catheter from the patient.The saber balloon catheter was then cut so it could be removed from the sheath.There was no reported injury to the patient.Additional information was requested but was not provided, and the device was not returned as expected.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
Complaint conclusion: as reported, after the successful inflation of a 6mm x 15cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter, the device became stuck inside of an unknown catheter sheath introducer (csi) and was unbale to be removed.It was reported that everything had to be removed, including the unknown csi, to remove the saber pta balloon catheter from the patient.The saber balloon catheter was then cut so it could be removed from the sheath.There was no reported injury to the patient.Additional information was requested but was not provided, and the device was not returned as expected.The device was not returned for analysis as expected.A product history record (phr) review of lot 82246610 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 withdrawal difficulty - through guide/sheath¿ could not be confirmed as the device was not returned for analysis.The exact cause cannot be determined.It is likely vessel characteristics, procedural factors and handling of the device contributed to the events reported.However, without return of the device for analysis it is difficult to draw a clinical conclusion between the device and the reported events.According to the warnings in the safety information in the instructions for use ¿prior to angioplasty, the catheter should be examined to verify functionality and integrity and ensure that its size and shape are suitable for the specific procedure for which it is to be used.Do not use if product damage is suspected or evident.To reduce the potential for vessel damage or the risk of dislodgement of particles it is very important that the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the lesion.The balloon dimensions are printed on the product label.The compliance table incorporated with the product shows how balloon diameter increases as pressure increases.Pressure in excess of the rated burst pressure can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath.Balloon rupture can cause vessel damage and the need for additional intervention.¿ according to the safety information of the instructions for use ¿if resistance is felt upon removal, then the balloon, guidewire and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected.Proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.Damage may result from kinking, stretching, or forceful wiping of the catheter.Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.Always verify integrity of the catheter after removal.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.

• Brand Name: SABER 6MM15CM 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: 15565756
• Report Number: 9616099-2022-06046
• Device Sequence Number: 5958898
• Product Code: LIT
• UDI-Device Identifier: 20705032069622
• UDI-Public: (01)20705032069622(17)250331(10)82246610
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2022

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: 03/31/2025
• Device Model Number: 48006015X
• Device Catalogue Number: 48006015X
• Device Lot Number: 82246610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2022
• Supplement Date Received by Manufacturer: 10/10/2022
• Initial Report FDA Received Date: 10/07/2022
• Supplement Report FDA Received Date: 10/18/2022
• Date Device Manufactured: 04/21/2022
• 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 CSI
• Patient Sex: Unknown