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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SABER 3MM4CM 90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL SABER 3MM4CM 90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 48003004S
Device Problem Burst Container or Vessel (1074)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/27/2019
Event Type  malfunction  
Manufacturer Narrative
A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, an unknown guide wire crossed the lesion; then a 3 mm x 4 cm 90 saber percutaneous transluminal angioplasty (pta) balloon dilatation catheter was inserted as a pre-dilation.However, it ruptured within its nominal pressure.The balloon did not inflate normally as it ruptured at 5 atmospheres.It was replaced with an unknown high-pressure balloon catheter and the procedure was completed.There was no injury to the patient.This was an endovascular therapy (evt) case.The lesion was the superficial femoral artery which had chronic total occlusion (cto).There was severe calcification of the lesion.There was no vessel tortuosity.The device was stored and handled per the instructions for use (ifu).The product did look normal when it was removed from its packaging.There was no difficulty removing the stylet or any of the sterile packaging components.There was no difficulty removing the product from the hoop.There was no difficulty removing the protective balloon cover.There were no kinks or other damages noted prior to inserting the product into the patient.The device was prepped per the ifu and prepped normally (i.E.Maintain negative pressure).The contrast to saline ratio was 1:1.A 9 x 40 non-cordis guidewire was used.A non-cordis inflation device was used and the same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.There was no resistance/friction while inserting the balloon through the guide catheter.The device did not have to pass through a previously placed stent.The catheter was never in an acute bend.Some force was when the device crossed.The products were removed intact (in one piece) from the patient.There were no other anomalies noted when the device was removed from the patient.Other additional procedural details were requested but were unknown.The device will not be returned for analysis because it was discarded.
 
Manufacturer Narrative
Complaint conclusion: an unknown guide wire crossed the lesion; then a 3mm x 4cm x 90 saber percutaneous transluminal angioplasty (pta) balloon dilatation catheter was inserted for pre-dilation.However, the balloon did not inflate normally as it ruptured at five atmospheres, within its nominal pressure.There was no injury to the patient.This was an endovascular therapy (evt) case.The lesion was the superficial femoral artery which had chronic total occlusion (cto).There was severe calcification of the lesion with no vessel tortuosity.It was replaced with an unknown high-pressure balloon catheter and the procedure was completed.The device was stored and handled per the instructions for use (ifu).The product was of normal appearance when it was removed from its packaging.There was no difficulty removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product into the patient.The device was prepped normally (i.E.Maintain negative pressure) per the ifu.The contrast to saline ratio was 1:1.A non-cordis guidewire and inflation device were used and 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 device did not have to pass through a previously placed stent.The catheter was never in an acute bend.Some force was used when the device crossed.The products were removed intact (in one piece) from the patient.There were no other anomalies noted when the device was removed from the patient.Other additional procedural details were requested but were unknown.The device was not returned for analysis as it was discarded.A product history record (phr) review of lot 82169720 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon-burst-at/below rbp¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics of severe calcification may have contributed to the reported event, as calcification is known to damage balloon material.However, without the return of the device for analysis it is difficult to draw a clinical conclusion between the device and the event reported.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.Do not exceed the rated burst pressure recommended on the label.The rated burst pressure is based on the results of in vitro testing.At least 99.9% of the balloons (with a 95% confidence) will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over-pressurization.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.Use only the recommended balloon inflation medium (a 50/50 mixture by volume of contrast medium and normal saline).Never use air or any gaseous medium to inflate the balloon.¿ 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.
 
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Brand Name
SABER 3MM4CM 90
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI 
MDR Report Key9512127
MDR Text Key199695723
Report Number9616099-2019-03429
Device Sequence Number1
Product Code LIT
UDI-Device Identifier20705032068069
UDI-Public20705032068069
Combination Product (y/n)N
PMA/PMN Number
K971010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2022
Device Model Number48003004S
Device Catalogue Number48003004S
Device Lot Number82169720
Was Device Available for Evaluation? No
Date Manufacturer Received12/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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