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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SABER RX4MM4CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL SABER RX4MM4CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 51004004L
Device Problems Balloon (419); Burst Container or Vessel (1074)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/05/2019
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: guiding sheath (6f destination, terumo)guidewire (235cm cruise, asahi intecc)balloon catheter (5mm*4cm shiden hp, kaneka). 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, a non-cordis 235cm guidewire crossed the lesion and a 4mm x 4cm 155¿ saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter was delivered to the lesion for pre-dilation. However, the balloon ruptured at 12 atmospheres (atm) during its initial 30-seconds inflation. Therefore, it was replaced with a new 5mm x 4cm kaneka shiden hp balloon catheter and the procedure was completed. There was no reported patient injury. The lesion was the left superficial femoral artery and it was heavily calcified with high stenosis. An ipsilateral approach was made with a 6f non-cordis guiding sheath. The device has been discarded in the hospital and will not be returned for analysis.

 
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Brand NameSABER RX4MM4CM155
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 Key9532111
MDR Text Key199871462
Report Number9616099-2019-03440
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,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 02/06/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/30/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2020
Device MODEL Number51004004L
Device Catalogue Number51004004L
Device LOT Number17716013
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 Received02/05/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/15/2017
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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