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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX5MM30CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION SABER RX5MM30CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number 51005030L
Device Problem Burst Container or Vessel (1074)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/21/2022
Event Type  malfunction  
Manufacturer Narrative
The product history review is expected but has not been completed. Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, the balloon of a 5mm x 30cm 155cm saberx percutaneous transluminal angioplasty (pta) balloon catheter ruptured during its initial inflation to 8 atmospheres (atm). As a result, the 5mm x 30cm 155cm saberx pta balloon catheter was removed and another 5mm x 30cm 155cm saberx pta balloon catheter was inserted and successfully inflated. An unknown stent was implanted, and the procedure was completed without injury to the patient. The target lesion was the superficial femoral artery (sfa) which had a stenosis and mild calcification. An unknown. 018 guidewire was inserted followed by an intravascular ultrasound (ivus) catheter and an ivus procedure was performed. The saberx pta was then inserted and inflated to 8 atm when it ruptured. The saberx pta was prepared with a 50/50 contrast-saline mixture. Additional information was requested but was not available, and the device was discarded and will not be returned for evaluation.
 
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Brand NameSABER RX5MM30CM155
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 Key13859126
MDR Text Key291238592
Report Number9616099-2022-05477
Device Sequence Number1
Product Code LIT
UDI-Device Identifier20705032076033
UDI-Public(01)20705032076033(17)240430(10)82222040
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 04/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number51005030L
Device Lot Number82222040
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/23/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/12/2021
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: 03/23/2022 Patient Sequence Number: 1
Treatment
OMNIPAQUE CONTRAST; SABER RX5MM30CM155; UNK STENT; UNK WIRE (0.018); UNKNOWN IVUS CATHETER
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