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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SABER 6MM30CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION SABER 6MM30CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 48006030X
Device Problem Burst Container or Vessel (1074)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/07/2022
Event Type  malfunction  
Event Description
As reported, the balloon of a 6mm x 30cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter ruptured at 6 atmospheres (atm) during an inflation in the superficial femoral artery (sfa). As a result, a 6mm x 30mm cordis balloon catheter was used to complete the procedure without any issues and there was no reported injury to the patient. The saber pta balloon catheter was being used post atherectomy via a 1. 7mm non-cordis atherectomy device and there were no issues experienced using the atherectomy device. The sfa lesion had a 76% stenosis and moderate calcification visualized by intravascular ultrasound (ivus) via an. 014 non-cordis ivus catheter, which also did not experience any difficulty during its use. There was no vessel tortuosity or presence of a chronic total occlusion (cto) at the target lesion. The device was stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation. There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components. Additionally, it was reported that staff had been trained prior to this procedure. There was no resistance or fiction experienced while inserting the balloon catheter into the patient and the device was able to cross the lesion with ease. After the balloon ruptured, the 6mm x 30cm 150cm saber pta was able to be removed easily and remained in one piece during removal from the patient. Information regarding the contrast to saline ratio was requested but not provided, and the device will be returned for evaluation.
 
Manufacturer Narrative
This device is available for analysis, but the engineering report is not yet available. However, it will be submitted within 30 days upon receipt. Additional information is pending and will be submitted within 30 days upon receipt.
 
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Brand NameSABER 6MM30CM 150
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 Key14023400
MDR Text Key293192438
Report Number9616099-2022-05522
Device Sequence Number1
Product Code LIT
UDI-Device Identifier20705032068182
UDI-Public(01)20705032068182(17)240831(10)82230548
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K971010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number48006030X
Device Catalogue Number48006030X
Device Lot Number82230548
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/27/2021
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: 04/06/2022 Patient Sequence Number: 1
Treatment
6MM X 30MM CORDIS BALLOON CATHETER; OMNIPAQUE CONTRAST; PHILLIPS .014 IVUS CATHETER; PHILLIPS PHOENIX ATHERECTOMY DEVICE 1.7MM
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