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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SABER RX3MM15CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL SABER RX3MM15CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number 51003015L
Device Problem Torn Material
Event Date 12/14/2017
Event Type  Malfunction  
Manufacturer Narrative

Device will not be returned for analysis as it was discarded. A review of the manufacturing documentation associated with this lot 17335227 presented no issues during the manufacturing process that can be related to the reported complaint. Additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

A saber rx 3 mm 15 cm 155 was inserted, but there was difficulty crossing the calcification. Then the distal tip got frayed. Therefore it was replaced with a new balloon catheter. The procedure completed successfully. There was no reported patient injury. The product was clinically used and it has been discarded in the hospital due to possible infectious disease and will not be returned for analysis. The target lesion was from the superficial femoral artery to the bk. The patient¿s information, patient¿s vessel level of tortuousness, vessel was calcified and rate of stenosis was unknown. Additional information has been requested.

 
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Brand NameSABER RX3MM15CM155
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 Key7173121
Report Number9616099-2018-01766
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 02/19/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/08/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2018
Device Catalogue Number51003015L
Device LOT Number17335227
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 Received02/14/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/23/2015
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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