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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SABER 5MM4CM 90 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL SABER 5MM4CM 90 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number 48005004S
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/26/2019
Event Type  malfunction  
Manufacturer Narrative
A review of the manufacturing documentation associated with lot (17718393) 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 pta balloon catheter (5mm4cm 90) was used for inflation. The wire lumen could be flushed without any issues. However, a thread like nylon about 1-centimeter (cm) came out when a guide wire was inserted. There was no reported patient injury. Therefore, a wire was removed and inserted after the flush. The procedure was completed. The lesion was the superficial femoral artery. Initially, the wire was used with another non-cordis balloon catheter before the saber pta balloon catheter was used. There was no evidence of anything attached to the wire. The product will not be returned for analysis as the device was discarded but the things like thread will be returned.
 
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Brand NameSABER 5MM4CM 90
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 Key8927702
MDR Text Key197111439
Report Number9616099-2019-03161
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K971010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/24/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2020
Device Catalogue Number48005004S
Device Lot Number17718393
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/08/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/22/2017
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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