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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SABER RX3MM4CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL SABER RX3MM4CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 51003004L
Device Problem Burst Container or Vessel (1074)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/21/2019
Event Type  malfunction  
Manufacturer Narrative
A review of the manufacturing documentation associated with lot 17637640 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, the 3mm 4cm 155 saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter (bc) ruptured at 4 to 5 atmosphere during its initial inflation and leakage of contrast media was confirmed. Therefore, it was replaced with a same size unknown balloon catheter and the procedure was completed. The device was taken out from the patient and there was no reported patient injury. The lesion was the superficial femoral artery. The device which had been stored in a hygiene-managed storage, was taken out from its tray and inspected. There were no anomalies confirmed. The doctor decided to insert the device and there was no issues confirmed with balloon set-up. The set-up was performed as per the instructions for use (ifu). A non-cordis guiding catheter was inserted from the common femoral artery to make a cross-over approach and was delivered to the lesion. A non-cordis guidewire crossed the lesion and an intravascular ultrasound (ivus) checked the lesion, which had diffuse calcification. There was slight resistance felt when it crossed the lesion. A non-cordis indeflator inflated the balloon. A smart stent was inserted to check the lesion by intravascular ultrasound (ivus). The device will not be returned as it has been discarded in the hospital due to the hospital regulation.
 
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Brand NameSABER RX3MM4CM155
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 Key9498920
MDR Text Key199694686
Report Number9616099-2019-03419
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 company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2019
Device Model Number51003004L
Device Catalogue Number51003004L
Device Lot Number17637640
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 Received01/17/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/25/2017
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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