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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX6MM4CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION SABER RX6MM4CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 51006004L
Device Problem Burst Container or Vessel (1074)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/14/2022
Event Type  malfunction  
Event Description
As reported, the balloon of a saber rx 6mm 4cm 155 ruptured at 16atm during second inflation after being inflated for 10 seconds. The procedure was completed after the use of a non-cordis balloon catheter of the same size. There was no reported injury to the patient. An approach was made from the left common femoral artery for a lesion in the right external iliac artery. A unknown guidewire crossed the lesion and the saber balloon was used for pre-dilation. The balloon was inflated to 16atm for 30 seconds during initial inflation. The device will not be returned for evaluation as it was discarded. Additional information was requested; however, the information could not be obtained.
 
Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
 
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Brand NameSABER RX6MM4CM155
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 Key14013991
MDR Text Key290463022
Report Number9616099-2022-05520
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 Received04/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number51006004L
Device Catalogue Number51006004L
Device Lot Number82222005
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/20/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/15/2021
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: 04/05/2022 Patient Sequence Number: 1
Treatment
BALLOON CATHETER (STERLING, BOSTON SCIENTIFIC).; UNK GUIDEWIRE
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