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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX6MM10CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION SABER RX6MM10CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 51006010L
Device Problem Burst Container or Vessel (1074)
Patient Problem Stenosis (2263)
Event Date 08/31/2021
Event Type  malfunction  
Manufacturer Narrative
This device is available for analysis but the engineering report is not yet available. A review of the manufacturing documentation associated with this lot#: 82193162 presented no issues during the manufacturing process that can be related to the reported complaint. However, it will be submitted within 30 days upon receipt.
 
Event Description
After implantation of an unknown stent, a 6mm x 10cm x 155cm saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter was inflated again, however, it ruptured. The balloon burst at approximate 8 atm. Initially, after a wire crossed a 20cm lesion, a saber pta balloon was used and inflated two times. There was no reported patient injury. The target lesion was the superficial femoral artery (sfa) with stenosis. A contralateral approach was made. There was no difficulty removing the product from the hoop or when removing the protective balloon cover. There was no difficulty removing the stylet or any of the sterile packaging components. There were no kinks or other damages noted prior to inserting the product the product into the patient. The device was prep normally. There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or when inserting the balloon through the guide catheter. The device will be returned for evaluation.
 
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Brand NameSABER RX6MM10CM155
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 Key12535985
MDR Text Key274534199
Report Number9616099-2021-04899
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 company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number51006010L
Device Catalogue Number51006010L
Device Lot Number82193162
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/15/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/09/2020
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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