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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX2MM30CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION SABER RX2MM30CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number 51002030L
Device Problem Burst Container or Vessel (1074)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/04/2022
Event Type  malfunction  
Event Description
As reported, the balloon of a 2mm x 30cm 155cm saberx percutaneous transluminal angioplasty (pta) balloon catheter ruptured during an inflation to 8 atmospheres (atm). As a result, the 2mm x 30cm 155cm saberx pta balloon catheter was removed and a 3mm x 30cm 155cm saberx pta balloon catheter was successfully used to complete the procedure without any issues. There was no reported injury to the patient. This was during an interventional procedure to treat a chronic totally occluded (cto) lesion in the superficial femoral artery (sfa). A contralateral approach was made, and an unknown. 014 guidewire was inserted passed the lesion, followed by the insertion of the 2mm x 30cm 155cm saberx pta balloon catheter. The device was discarded and will not be returned for evaluation.
 
Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
 
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Brand NameSABER RX2MM30CM155
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 Key14250167
MDR Text Key290379932
Report Number9616099-2022-05600
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,Followup
Report Date 05/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number51002030L
Device Lot Number82227645
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/29/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/13/2021
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: 04/29/2022 Patient Sequence Number: 1
Treatment
3MM X 30CM 155CM SABERX PTA BALLOON CATHETER; UNK GUIDEWIRE (0.014)
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