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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SABER 6MM2CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL SABER 6MM2CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 48006002X
Device Problems Crack; Catheter; Tip
Event Date 04/16/2018
Event Type  Malfunction  
Manufacturer Narrative

Complaint conclusion: as reported, the 6 x 20 mm 150 cm saber balloon was damaged. The issue was further clarified as the device was kinked/bent, fractured at the tip. There was no reported patient injury. The malfunction was noticed during prep. The device was not prepped normally (i. E. Maintain negative pressure). There was no difficulty removing the product from the hoop, the protective balloon cover, or the stylet or any of the sterile packaging components. The device was not used inside the patient. The product was not returned for analysis. A device history record (dhr) review of lot 17588608 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. The reported ¿distal tip cracked during prep¿ could not be confirmed as the device was not returned for analysis. The exact cause of the fractured tip could not be determined. Based on the limited information available for review, handling factors may have contributed to the reported event. According to the instructions for use, which is not intended as a mitigation, ¿prior to angioplasty, the catheter should be examined to verify functionality and integrity and ensure that its size and shape are suitable for the specific procedure for which it is to be used. Do not use if product damage is suspected or evident. 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 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, the saber (6 mm 2 cm 150) balloon was damaged. There was no reported patient injury. The product will not be returned. The device was kinked and bent, fractured at the tip. The malfunction was noticed during prep. The device was not prepped normally (i. E. Maintain negative pressure). There was no difficulty removing the product from the hoop, the protective balloon cover, or the stylet or any of the sterile packaging components. The device was not used inside the patient.

 
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Brand NameSABER 6MM2CM 150
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
MDR Report Key7546474
Report Number9616099-2018-02158
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 06/29/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/25/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2019
Device MODEL Number48006002X
Device Catalogue Number48006002X
Device LOT Number17588608
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 Received05/30/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/20/2016
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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