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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX5MM15CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION SABER RX5MM15CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 51005015L
Device Problem Burst Container or Vessel (1074)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/19/2021
Event Type  malfunction  
Manufacturer Narrative
As reported, the balloon of a saber rx 5mm15cm155 percutaneous transluminal angioplasty (pta) balloon catheter ruptured at eight atm. The device was replaced with a new, unknown balloon catheter and the procedure was completed. There was no reported patient injury. The lesion was at the superficial femoral artery (sfa). The lesion was severely calcified, moderately tortuous and was a cto. There was no difficulty removing the product from the hoop, removing the protective balloon cover, removing the stylet, or any of the sterile packaging components. The device was stored and prepped as per the instructions for use (ifu). There were no kinks or other damages noted prior to inserting the product into the patient. The device prepped normally. A non-cordis indeflator was used and the same indeflator was used successfully with other devices. The plunger did depress into the indeflator when trying to inflate. There was no resistance/friction while inserting the balloon through the rotating hemostatic valve and no resistance/friction while inserting the balloon through the guide catheter. There was no difficulty advancing the balloon catheter through the vessel. There was difficulty crossing the lesion and there was acute bend(s). Other procedural details were requested but are unknown, unavailable, or not applicable. The product was not returned for analysis as it was discarded by mistake. A product history record (phr) review of lot 82211814 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 with moderate tortuosity and a chronic total occlusion likely contributed to the reported event as calcification is known to cause damage to 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.
 
Event Description
As reported, the balloon of a saber rx 5mm15cm155 percutaneous transluminal angioplasty (pta) balloon catheter ruptured at 8atm. The device was replaced with a new, unknown balloon catheter and the procedure was completed. There was no reported patient injury. The lesion was at the superficial femoral artery (sfa). The lesion was severely calcified and moderately tortuous and was a cto. There was no difficulty removing the product from the hoop, removing the protective balloon cover, or removing the stylet or any of the sterile packaging components. The device was stored and prepped as per the instructions for use (ifu). There were no kinks or other damages noted prior to inserting the product the product into the patient. The device prepped normally. A non cordis indeflator was used and the same indeflator was used successfully with other devices. The plunger did depress into the indeflator when trying to inflate. There was no resistance/friction while inserting the balloon through the rotating hemostatic valve and no resistance/friction while inserting the balloon through the guide catheter. There was no difficulty advancing the balloon catheter through the vessel. There was difficulty crossing the lesion and there was acute bend(s). Other procedural details were requested but are unknown, unavailable, or not applicable. The device will not be returned for analysis because it was discarded by mistake.
 
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Brand NameSABER RX5MM15CM155
Type of DeviceCATHETER, 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 Key13017764
MDR Text Key282329171
Report Number9616099-2021-05198
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K971010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number51005015L
Device Catalogue Number51005015L
Device Lot Number82211814
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/19/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/09/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/16/2021 Patient Sequence Number: 1
Treatment
UNK BALLOON CATHETER, ABBOT INDEFLATOR
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