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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX5MM30CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION SABER RX5MM30CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number N/A
Device Problems Crack (1135); Material Frayed (1262); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/14/2021
Event Type  malfunction  
Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82204954 presented no issues during the manufacturing process that can be related to the reported event. This device is available for analysis but the engineering report is not yet available. However, it will be submitted within 30 days upon receipt. Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, pre-dilation was done and the 5mm x 30cm 155 saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter was used but the distal tip got broken. The distal tip got kinked 1cm from the distal end. It was about to come off. Therefore, the device was replaced with another device with different lot number and the procedure continued. There was no reported patient injury. The device was stored and prepped as per the instructions for use (ifu). The device was not resterilized. There were no anomalies noted when removed from the package. There were no anomalies noted during prep. The lesion was the superficial femoral artery which had chronic total occlusion (cto). A contralateral approach was made with a 6f non-cordis guiding sheath. Other procedural details were requested but are unknown, unavailable, or not applicable. The device will be returned for analysis.
 
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Brand NameSABER RX5MM30CM155
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60 avenue
miami lakes, FL 33014
7863138372
MDR Report Key11973133
MDR Text Key255990356
Report Number9616099-2021-04625
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
N/A
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 07/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number51005030L
Device Lot Number82204954
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/09/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/17/2020
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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