MAUDE Adverse Event Report: CORDIS CORPORATION SABER 2MM20CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	48002020X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the shaft of the saber 2mm20cm 150 balloon was broken.There was no reported patient injury.The product was returned for evaluation.A leak on the body/shaft of the unit was present, revealing a damage on the body shaft surface.Sem analysis showed a rupture on the body shaft surface.
Additional Manufacturer Narrative
Complaint conclusion: as reported, the shaft of the saber 2mm x 20cm 150 balloon was broken.There was no reported patient injury.The product was returned for analysis.A non-sterile saber 2mm x 20cm 150 percutaneous transluminal angioplasty (pta) balloon catheter was received for analysis inside a clear plastic bag.Per visual analysis, no anomalies could be seen by the naked eye.Per functional analysis, a lab sample syringe filled with water was attached to the guide wire lumen of the saber and positive pressure was applied.A leak on the body shaft of the unit was present revealing damage on the body shaft surface.No other anomaly was observed.Per microscopic analysis, sem showed the body/shaft damage was caused by a rupture on the body shaft surface.The external surface of the body shaft presented evidence of micro-tears and scratch marks near the body shaft rupture.This type of damage is commonly caused during the interaction of the device material with a sharp object or mechanical damage.Likely, the same factors that caused the observed micro-tears and scratch marks on the body shaft outer surface probably led to the ruptured condition found on the received body shaft.The internal surface of the body shaft did not present evidence of damages on the surrounding areas of the rupture.It seems the body shaft material near the rupture was torn either due to the interaction of the body shaft with calcified spicules located on the lesion or with a sharp object from the outside of the body shaft.No other anomalies were found during the sem analysis.A product history record (phr) review of lot 82227853 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿body/shaft burst¿ was confirmed via device analysis.However, the exact cause cannot be determined.A leakage was confirmed during functional analysis as a rupture was noted on the outer surface of the shaft as scratch marks were also noted leading up to the rupture.It is likely vessel characteristics although unknown, contributed to the reported event as evidenced by device analysis.The shaft material near the rupture, appears to have been torn either due to the interaction of calcified spicules located on the lesion or with a sharp object from the outside of the body/shaft.According to the safety information in the instructions for use ¿when the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation.Do not advance or retract the catheter unless the balloon is fully deflated under vacuum.If resistance is met during manipulation, determine the cause of resistance before proceeding.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 2MM20CM 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: 13237852
• Report Number: 9616099-2022-05291
• Device Sequence Number: 4330499
• Product Code: LIT
• UDI-Device Identifier: 20705032069219
• UDI-Public: (01)20705032069219(17)240731(10)82227853
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/12/2022

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: 07/31/2024
• Device Model Number: 48002020X
• Device Catalogue Number: 48002020X
• Device Lot Number: 82227853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2021
• Initial Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2021
• 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