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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SABER 3MM4CM 90 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL SABER 3MM4CM 90 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 48003004S
Device Problem Burst Container or Vessel (1074)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/27/2019
Event Type  Malfunction  
Manufacturer Narrative

A review of the manufacturing documentation associated with this lot 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

As reported, an unknown guide wire crossed the lesion; then a 3 mm x 4 cm 90 saber percutaneous transluminal angioplasty (pta) balloon dilatation catheter was inserted as a pre-dilation. However, it ruptured within its nominal pressure. The balloon did not inflate normally as it ruptured at 5 atmospheres. It was replaced with an unknown high-pressure balloon catheter and the procedure was completed. There was no injury to the patient. This was an endovascular therapy (evt) case. The lesion was the superficial femoral artery which had chronic total occlusion (cto). There was severe calcification of the lesion. There was no vessel tortuosity. The device was stored and handled per the instructions for use (ifu). The product did look normal when it was removed from its packaging. There was no difficulty removing the stylet or any of the sterile packaging components. There was no difficulty removing the product from the hoop. There was no difficulty removing the protective balloon cover. There were no kinks or other damages noted prior to inserting the product into the patient. The device was prepped per the ifu and prepped normally (i. E. Maintain negative pressure). The contrast to saline ratio was 1:1. A 9 x 40 non-cordis guidewire was used. A non-cordis inflation device was used and the same indeflator was used successfully with other devices. There was no resistance/friction while inserting the balloon through the rotating hemostatic valve. There was no resistance/friction while inserting the balloon through the guide catheter. The device did not have to pass through a previously placed stent. The catheter was never in an acute bend. Some force was when the device crossed. The products were removed intact (in one piece) from the patient. There were no other anomalies noted when the device was removed from the patient. Other additional procedural details were requested but were unknown. The device will not be returned for analysis because it was discarded.

 
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Brand NameSABER 3MM4CM 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 Key9512127
MDR Text Key199695723
Report Number9616099-2019-03429
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK971010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 12/31/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/23/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number48003004S
Device Catalogue Number48003004S
Device LOT Number82169720
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 Received12/30/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/09/2019
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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