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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX5MM6CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION SABER RX5MM6CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 51005006L
Device Problem Structural Problem (2506)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/03/2020
Event Type  malfunction  
Manufacturer Narrative
Complaint conclusion: as reported, a 5mm x 6cm x 155cm saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter was used for inflation, but the position of the proximal marker and the balloon shoulder were out of position about one cm. Therefore, it was replaced with non-cordis balloon catheter, and the procedure was completed. There was no reported patient injury. The device was not returned for analysis as it was discarded due to suspicious infectious disease. A product history record (phr) review of lot 82181108 revealed no anomalies or non-conformances during the manufacturing, and inspection processes that can be associated with the reported event. The reported ¿marker band-balloon catheters- offset/out of position-in patient¿ could not be confirmed as the device was not returned for analysis. Therefore, specification orientation of marker bands cannot be confirmed. The exact cause could not be determined. With the information available and without the return of the product or films of the procedure, it is not possible to draw a clinical conclusion between the device and the event. However, vessel characteristics and procedural factors may have contributed to the reported event. According to the device description in the safety information in the instructions for use ¿the cordis saber percutaneous transluminal angioplasty (pta) dilatation catheter is a catheter with a distal inflatable balloon. Radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. For balloon lengths greater than or equal to 100mm, the distal section will have one (1) marker band and proximal section will consist of two (2) adjacent marker bands. For balloon lengths less than 100mm, the distal and proximal section will have each one (1) marker band. The catheter tip is tapered to ease entry into peripheral arteries and to facilitate the crossing of tight stenoses. The radiopaque marker bands (the length between the outer edge of most proximal to the outer edge of most distal marker band) indicate the stated nominal length of the balloon. ¿ neither the phr, 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 5mm x 6cm x 155cm saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter was used for inflation but the position of the proximal marker, and the balloon shoulder were out of position about 1cm. Therefore, it was replaced with non-cordis balloon catheter, and the procedure was completed. There was no reported patient injury. The device will not be returned for evaluation as it was discarded due to suspicious infectious disease.
 
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Brand NameSABER RX5MM6CM155
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 60th ave
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key10540266
MDR Text Key207136412
Report Number9616099-2020-03907
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,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number51005006L
Device Catalogue Number51005006L
Device Lot Number82181108
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 Received09/03/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/12/2019
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: 09/16/2020 Patient Sequence Number: 1
Treatment
NON-CORDIS BALLOON
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