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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SABER RX5MM10CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL SABER RX5MM10CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number 51005010L
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/25/2017
Event Type  malfunction  
Manufacturer Narrative
As reported, a 5x150mm 155cm saber rx percutaneous transluminal angioplasty (pta) balloon catheter was delivered to the lesion and inflated for pre-dilatation. However, it was delivered again for a post ¿dilatation, and the distal tip was confirmed to have come off. The saber rx pta balloon catheter was removed from the patient and the distal tip was fixed. After this, a different size new balloon catheter completed the procedure. The procedure was completed successfully. There was no reported patient injury. The target lesion was the iliac artery. The lesion was heavily calcified. The patient¿s vessel level of tortuousness was unknown. The rate of stenosis was unknown. Initially, there were no anomalies confirmed on the device before and during use. The tip was on the guidewire, and both were removed together from the patient. The separated distal tip will be returned for analysis with the complaint product. As of note: ¿the physician commented that the reason of this issue seemed to be due to heavy calcification¿. The device was not returned for analysis. A device history record (dhr) review of lot 17605007 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. The reported ¿distal tip separated¿ could not be confirmed as the device was not returned for analysis. The exact cause could not be determined. Based on the limited information provided, vessel characteristics (crossing a heavily calcified lesion) and procedural/handling factors may have contributed to the reported event. According to the instructions for use (ifu), ¿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.
 
Manufacturer Narrative
A review of the manufacturing documentation associated with this lot (17605007) presented no issues during the manufacturing process that can be related to the reported event. Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, a saber rx pta balloon catheter (5 mm 15 cm 155) was delivered to the lesion and inflated as a pre dilatation. Then, it was delivered again for a post dilatation. However, the distal tip was confirmed to have been come off. The saber rx pta balloon catheter was removed from the patient and the distal tip was fixed. After this, a different size new balloon catheter completed the procedure. The procedure was completed successfully. There was no reported patient injury. The target lesion was the iliac artery. The lesion was heavily calcified. The patient¿s vessel level of tortuousness was unknown. The rate of stenosis was unknown. Initially, there were no anomalies confirmed on the device before and during use. The tip was on the guidewire, and both were removed together from the patient. The separated distal tip will be returned for analysis with the complaint product. As of note: ¿the physician commented that the reason of this issue seemed to be due to heavy calcification¿.
 
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Brand NameSABER RX5MM10CM155
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 Key7206271
MDR Text Key195838131
Report Number9616099-2018-01794
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 foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2019
Device Catalogue Number51005010L
Device Lot Number17605007
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 Received02/04/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/14/2016
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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