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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SABER RX4MM30CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL SABER RX4MM30CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 51004030L
Device Problems Indicator; Structural Problem; Catheter
Event Date 02/06/2019
Event Type  Malfunction  
Manufacturer Narrative

A saber rx (4mm x 30cm x 155cm) percutaneous transluminal angioplasty (pta) balloon catheter (bc) was deflated and it was confirmed that the junction between the balloon part and the shaft section was lengthened. There was no reported patient injury. The proximal marker was confirmed not to be in the proper position. One product was returned for analysis. A non-sterile saber rx 4mm x 30cm x 155cm was returned. Per visual inspection the bc was coiled inside a clear plastic bag, the balloon was not inflated. No damages or anomalies were observed on the body of the catheter nor at the balloon. A dimensional analysis was performed to verify the correct distance between the distal and the proximal marker bands. The measurement was found to be within specification. A product history record (phr) review of lot 82153637 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" and ¿body/shaft-unraveled stretched" was not confirmed by analysis of the returned device. The exact cause could not be confirmed as dimensional analysis was performed and the measurement was found to be within specification. Furthermore, no damages or anomalies were observed on the body of the catheter nor at the balloon. The device performed as intended; 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. ¿ according to the safety information of the instructions for use ¿if resistance is felt upon removal, then the balloon, guidewire and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected. Proper functioning of the catheter depends on its integrity. Care should be used when handling the catheter. Damage may result from kinking, stretching, or forceful wiping of the catheter. Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces. Always verify integrity of the catheter after removal. ¿ 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 saber rx (4mm 30cm 155) percutaneous transluminal angioplasty (pta) balloon catheter was deflated and it was confirmed that the junction between the balloon part and the shaft section was lengthened. There was no reported patient injury. The proximal marker was confirmed not to be in the proper position.

 
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Brand NameSABER RX4MM30CM155
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI 
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, co. tipperary
EI 
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes , FL 33014
7863138372
MDR Report Key8403734
Report Number9616099-2019-02768
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 03/08/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/08/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number51004030L
Device Catalogue Number51004030L
Device LOT Number82153637
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/12/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/06/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/15/2018
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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