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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
Model Number N/A
Device Problem Burst Container or Vessel (1074)
Patient Problem Stenosis (2263)
Event Date 11/17/2020
Event Type  malfunction  
Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82176352 presented no issues during the manufacturing process that can be related to the reported event. Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, a 2mm x 30cm x 155cm saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter was used; but it ruptured within its nominal pressure during its second inflation. Therefore, the device was replaced with a 2 x 15 saber rx pta balloon and the procedure was completed. There was no reported patient injury. The lesion was the right posterior tibial artery which had calcification and continuous severe stenosis. An ipsilateral approach was made from the femoral artery by using a 4. 5f 55cm non-cordis sheath. Some concomitant devices including a non-cordis microcatheter and non-cordis guidewire crossed the lesion. The device will not be returned for evaluation as it was discarded in the hospital.
 
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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 Key10965019
MDR Text Key222306781
Report Number9616099-2020-04102
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2022
Device Model NumberN/A
Device Catalogue Number51002030L
Device Lot Number82176352
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/22/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/27/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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