MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX6MM10CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51006010L

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2020

Event Type  malfunction  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

As reported, the 6mm x 10cm x 155cm saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter was used but contrast media leaked from the indeflator (unknown) when the second pta was performed.It was removed from the patient and confirmed that it was kinked at the proximal balloon part and the contrast media leaked from there.There was no reported patient injury.The lesion was the superficial femoral artery.There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.There were no kinks nor other damages noted prior to inserting the product into the patient.The device was prep normally (i.E.Maintain negative pressure).Iopamidol contrast media was used.The saline:contrast media ratio was 2:1.An encore, boston scientific inflation device was used.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or the guide catheter.The lesion had no tortuosity, with 50% calcification, and 100% stenosis.The device was used for a chronic total occlusion (total occlusion >3 months).There was no difficulty advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion.The catheter was never in an acute bend.The balloon catheter did not kink while being used.The product was removed intact (in one piece) from the patient.The device will be returned for analysis.

Manufacturer Narrative

Complaint conclusion: as reported, the 6mm x 10cm x 155cm saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter was used but contrast media leaked from the indeflator (unknown) when the second pta was performed.It was removed from the patient and confirmed that it was kinked at the proximal balloon part and the contrast media leaked from there.There was no reported patient injury.The lesion was the superficial femoral artery.There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.There were no kinks nor other damages noted prior to inserting the product into the patient.The device was prepped normally (i.E.Maintain negative pressure).Non-cordis contrast media was used and the saline to contrast media ratio was 2:1.A non-cordis inflation device was used was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or the guide catheter.The lesion had no tortuosity, with 50% calcification, and 100% stenosis.The device was used for a chronic total occlusion (total occlusion >3 months).There was no difficulty advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion.The catheter was never in an acute bend.The balloon catheter did not kink while being used.The product was removed intact (in one piece) from the patient.The device was returned for analysis.A non-sterile saber rx 6mm x 10cm 155 was received for analysis coiled inside a plastic bag.Per visual analysis, the balloon had been previously inflated.Blood residues were observed inside the balloon.The unit was thoroughly inspected at naked eye and no other anomalies were observed.Per functional analysis, balloon inflation was performed.A lab inflator/deflator device was attached to the inflation lumen of unit and pressure applied.A leakage of water was observed coming from a torn area of the body/shaft near the balloon.Per sem analysis on the unit¿s torn condition observed during inflation test, results showed that the torn body/shaft was caused by a rupture on the body/shaft area.The outer surface presented evidence of scratch marks near the body/shaft area rupture.This type of damage is commonly caused during the interaction of the body/shaft material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks on the body/shaft area surface probably led to the ruptured condition found on the received device.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 observed during the sem analysis.A product history record (phr) review of lot 82181109 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿body/shaft leakage - in-patient¿ was confirmed during device analysis.The reported ¿body/shaft kinked/bent - in-patient¿ was not confirmed as no kinks or bends were noted on the device.The exact cause could not be determined.Device analysis revealed a leakage of water coming prom a torn area on the body/shaft of the device, scratch marks adjacent to the torn/ruptured area most likely led to the ruptured condition found on the received device.Based on the information provided it appears the body/shaft leakage/rupture was caused by the interaction of the shaft material with a sharp object.It is likely vessel characteristics of calcification, 100% stenosis and a chronically occluded vessel, contributed to the reported event as calcified spicules may easily damage the shaft of the device.According to the instructions for use, which are not intended to mitigate risk, ¿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.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 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 RX6MM10CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 10779202
• MDR Text Key: 214543793
• Report Number: 9616099-2020-04033
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/19/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 51006010L
• Device Catalogue Number: 51006010L
• Device Lot Number: 82181109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Initial Date Manufacturer Received: 10/09/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 11/04/2020
• Supplement Dates FDA Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK INDEFLATOR