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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SABER 6MM4CM 90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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CORDIS CORPORATION SABER 6MM4CM 90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 48006004S
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Failure of Implant (1924)
Event Date 09/15/2020
Event Type  Injury  
Manufacturer Narrative
A review of the manufacturing documentation associated with lot (82189388) presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, the 6mm x 4cm 90 saber percutaneous transluminal angioplasty (pta) balloon dilatation catheter was implanted and deployed in patient, but the balloon then ¿snapped off¿.The shaft has been retrieved but the balloon was left in patient.
 
Manufacturer Narrative
Section b5: additional information received indicates that the target lesion was the superficial femoral artery (sfa).There were no visible signs of device/package damage prior to use.There were no anomalies when the device was taken out of the package.The device was pulled from the packaging by the hub.The device wad prepped according to the instructions for use (ifu).There was no difficulty encountered while flushing the balloon catheter.There was no difficulty encountered connecting the hub to the indeflator device.There was no difficulty advancing the balloon catheter through the vessel.There was no unusual force used at any time during the procedure.There was no reported patient injury and the patient is noted to be fine.The patient was neither hospitalized nor was the patient's hospitalization extended because of the event.The patient is noted to have recovered.Additional information is pending and will be submitted within 30 days upon receipt.
 
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.
 
Manufacturer Narrative
As reported, the 6mm x 4cm 90 saber percutaneous transluminal angioplasty (pta) balloon dilatation catheter was implanted and deployed in patient, but the balloon then ¿snapped off¿.The shaft has been retrieved but the balloon was left in patient.The target lesion was the superficial femoral artery (sfa).There were no visible signs of device/package damage prior to use.There were no anomalies when the device was taken out of the package.The device was pulled from the packaging by the hub.The device was prepped according to the instructions for use (ifu).There was no difficulty encountered while flushing the balloon catheter.There was no difficulty encountered connecting the hub to the indeflator device.There was no difficulty advancing the balloon catheter through the vessel.There was no unusual force used at any time during the procedure.There was no reported patient injury, and the patient is noted to be fine.The patient was neither hospitalized nor was the patient's hospitalization extended because of the event.The patient is noted to have recovered.One product was returned for analysis.A non-sterile saber 6mm x 4cm 90 was received for analysis coiled inside a plastic bag.An unknown guidewire was received inserted into the unit, as received.Per visual analysis, the balloon and the body/shaft of the unit were observed separated, as received.No other anomalies were observed.Per sem analysis on the separated balloon and separated body/shaft observed during the visual review, results showed that the balloon separation was caused by a rupture on the balloon surface.The inner surface presented no anomalies near the balloon rupture.The outer surface presented evidence of scratch marks near the balloon rupture.The body/shaft material presented elongations near the body/shaft separation.This type of damage is commonly caused during the interaction of the balloon material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks on the balloon outer surface could probably led to the rupture condition found on the received device.Also, the elongations observed on the body/shaft material suggest that the unit experienced pulling/stretch events.It seems the balloon material near the rupture was torn either due to the interaction of the balloon with calcified spicules located on the lesion or with a sharp object from the outside of the balloon.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 82189388 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon - separated - in-patient¿ was confirmed during device analysis as the balloon was observed separated, as well as the body/shaft.Per sem analysis the balloon separation, this appears to have been caused by a rupture on the balloon.The balloon material presented evidence of scratch marks near the rupture.The body/shaft separation was caused seemingly by a pulling/stretch event which suggests the device was induced to events that exceeded the material yield strength prior to the separation.It is likely procedural factors and handling of the device contributed to the events reported by the customer.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.¿ according to the warnings in the safety information in 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.¿ neither the phr review, nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process.Therefore, no corrective or preventive action will be taken at this time.
 
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Brand Name
SABER 6MM4CM 90
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th ave
miami lakes FL 33014
MDR Report Key10670902
MDR Text Key211308233
Report Number9616099-2020-03970
Device Sequence Number1
Product Code LIT
UDI-Device Identifier20705032068748
UDI-Public20705032068748
Combination Product (y/n)N
PMA/PMN Number
K971010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup,Followup
Report Date 12/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2023
Device Model Number48006004S
Device Catalogue Number48006004S
Device Lot Number82189388
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2020
Initial Date Manufacturer Received 09/15/2020
Initial Date FDA Received10/13/2020
Supplement Dates Manufacturer Received10/12/2020
11/03/2020
12/01/2020
Supplement Dates FDA Received11/09/2020
12/02/2020
12/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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