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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX6MM20CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION SABER RX6MM20CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number 51006020L
Device Problem Deflation Problem (1149)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/17/2022
Event Type  malfunction  
Event Description
As reported, after pre-dilation of a chronic totally occluded (cto) lesion in the left superficial femoral artery (sfa), the balloon of a 6mm x 20cm 155cm saberx percutaneous transluminal angioplasty (pta) balloon catheter took over twice the normal time to deflate. The balloon was eventually deflated, and a new, different sized saberx pta balloon catheter was used in its place to complete the procedure. There was no reported injury to the patient. Additional information was requested but was unavailable, and the device was discarded and will not be retuned for evaluation.
 
Manufacturer Narrative
Complaint conclusion: as reported, after pre-dilation of a chronic totally occluded (cto) lesion in the left superficial femoral artery (sfa), the balloon of a 6mm x 20cm 155cm saberx percutaneous transluminal angioplasty (pta) balloon catheter took over twice the normal time to deflate. The balloon was eventually deflated, and a new, different sized saberx pta balloon catheter was used in its place to complete the procedure. There was no reported injury to the patient. Additional information was requested but was unavailable. The device was not returned for analysis. A product history record (phr) review of lot 82193164 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. The reported ¿balloon deflation difficulty - partial or slow¿ could not be confirmed as the device was not returned for analysis. The exact cause of the reported events cannot be determined. Based on the events reported the balloon was being used for pre-dilation of a chronically occluded lesion. It is likely damage to the balloon material occurred upon inflation or during the attempt to cross the cto lesion. 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, ¿flush all devices entering the vascular system with sterile heparinized saline or similar isotonic solution. Prior to use, ensure all devices have been flushed and air is removed from the system according to standard medical practice. Failure to do so could result in air entering the vascular system. 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. 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. Deflate the balloon by pulling vacuum on the inflation syringe or inflation device. Apply negative pressures to the balloon for about 30 - 85 seconds until the balloon is deflated. Remove the vacuum (do not apply pressure) and carefully withdraw and remove the catheter. ¿ 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 NameSABER RX6MM20CM155
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 Key14110447
MDR Text Key289292051
Report Number9616099-2022-05547
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
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 04/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number51006020L
Device Lot Number82193164
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/17/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/10/2020
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: 04/14/2022 Patient Sequence Number: 1
Treatment
SABERX PTA
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