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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORTION SABER 5MM4CM 90 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORTION SABER 5MM4CM 90 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number N/A
Device Problems Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)
Patient Problems Myocardial Infarction (1969); Pneumonia (2011)
Event Date 09/09/2019
Event Type  Injury  
Manufacturer Narrative
The device was returned but the engineering report is pending. A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan. Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
When performing a recanalisation of the common iliac artery with a 5x40 mm saber balloon to create a larger lumen for a bigger balloon, the balloon burst during dilatation, and was stuck. When they tried to pull the balloon, it split up and a piece of it was stuck in the artery. It was dragged down to common femoral artery with a guidewire that also was also stuck in a piece of the balloon. The balloon piece was removed with a surgery via the groin with general anesthesia. The patient had a postoperative heart attack and died one week later. The patient remained hospitalized following the surgery and heart attack. An autopsy was not performed. The death certificate listed the official cause of death as heart attack and pneumonia. The device will be returned for analysis. The lesion was calcified and a chronic total occlusion (cto). There were no kinks or other damages noted prior to inserting the product the product into the patient. The device prepped normally. The brand of contrast was omnipak 300 at a 50:50 contrast to saline ratio with an everest inflation device by medtronic. The same indeflator was used successfully with other devices. There was no resistance/friction while inserting the balloon through the rotating hemostatic valve. There was no resistance/friction while inserting the balloon through the guide catheter. There difficulty advancing the balloon catheter through the vessel and crossing the lesion. The catheter was never in an acute bend. The balloon inflated normally and the maximum inflation pressure was 5-6 atmospheres. The balloon was not caught in the lesion or in a deployed stent. There was resistance met while withdrawing the device from the vessel, into the guide catheter, into the introducer guide and through the hemostasis valve. The patient had the heart attack a few hours after the procedure which was treated medically.
 
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Brand NameSABER 5MM4CM 90
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CORPORTION
14201 nw 60th ave
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60th ave
miami lakes 33014
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key9179219
MDR Text Key162049611
Report Number9616099-2019-03268
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeNO
PMA/PMN Number
K971010
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 10/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2020
Device Model NumberN/A
Device Catalogue Number48005004S
Device Lot Number17683882
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/02/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/24/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/14/2017
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: 10/11/2019 Patient Sequence Number: 1
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