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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SABER 6MM4CM 90 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION SABER 6MM4CM 90 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number 48006004S
Device Problem Burst Container or Vessel (1074)
Patient Problem Not Applicable (3189)
Event Date 11/16/2018
Event Type  malfunction  
Manufacturer Narrative
As reported, a 6x40mm 90cm saber percutaneous transluminal angioplasty (pta) dilation catheter was inserted and inflated for a shunt case. However, it ruptured. No patient injury was reported. No additional information was provided. The device was not returned for analysis. A device history record (dhr) review of lot 17672292 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. The reported ¿balloon burst¿ could not be confirmed as the device was not returned for analysis. The exact cause of the burst could not be determined. Based on the limited information available for review, vessel characteristics (although not provided) and procedural/handling factors may have contributed to the reported event since calcified/resistant lesions can damage the balloon. According to the instructions for use, which is not intended as a mitigation, ¿the rated burst pressure is based on the results of in vitro testing. At least 99. 9% of the balloons (with a 95% confidence) will not burst at or below their rated burst pressure. Use of a pressure monitoring device is recommended to prevent over-pressurization. Do not exceed the rated burst pressure recommended on the label. Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used. ¿ neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event. Therefore, no corrective/preventive action will be taken at this time.
 
Event Description
As reported, a 90 6mmx4cm saber percutaneous transluminal angioplasty (pta) dilation catheter was inserted and inflated for a shunt case. However, it ruptured. No patient injury was reported. No additional information was provided.
 
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Brand NameSABER 6MM4CM 90
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 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key8166668
MDR Text Key130494521
Report Number9616099-2018-02585
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
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
Report Date 12/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2020
Device Catalogue Number48006004S
Device Lot Number17672292
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 Received11/16/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/11/2017
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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