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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SABER RX8MM4CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL SABER RX8MM4CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 51008004L
Device Problem Burst Container or Vessel (1074)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/12/2019
Event Type  malfunction  
Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82168836 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, an 8mm x 4cm 155 saber percutaneous transluminal angioplasty (pta) rapid exchange (rx) balloon catheter (bc) ruptured at approximately 4 atmospheres (atm) post dilation. Therefore, the device was removed intact in one piece from the patient and it was replaced with a new non-cordis balloon catheter and the procedure was completed. There was no reported patient injury. The device was stored and handled as per the instruction for use (ifu). There was no damage noted to the packaging of the device prior to use. The device was prepped according to the ifu. The device was prepped normally (i. E. Maintain negative pressure). The target lesion was the iliac artery with 99% stenosis. The device was not used for a chronic total occlusion (total occlusion >3 months). There was no difficulty removing the product from the hoop. There was no difficulty removing the protective balloon cover. There was no difficulty removing the stylet or any of the sterile packaging components. The same indeflator was used successfully with other devices. There was no resistance/friction while inserting the balloon through the rotating hemostatic valve. There were no guiding catheters used in the procedure. An ipsilateral approach was made from the femoral artery using a non-cordis sheath. Pre-dilation was performed with an unknown 6mm balloon catheter and a 12mm and 10mm smart stent was implanted. There was no difficulty advancing the balloon catheter through the vessel. There was no difficulty crossing the lesion. The catheter was not ever in an acute bend. The maximum inflation pressure was between 3-5 atmospheres (atm). The balloon did not seem to ¿stick¿ to a stent. The device will not be returned for evaluation as it was discarded due to infectious disease. Additional procedural details were requested but are unknown.
 
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Brand NameSABER RX8MM4CM155
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 Key9448533
MDR Text Key199106712
Report Number9616099-2019-03395
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,Followup
Report Date 01/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number51008004L
Device Catalogue Number51008004L
Device Lot Number82168836
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 Received01/13/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/04/2019
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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