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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX2MM30CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION SABER RX2MM30CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 51002030L
Device Problem Structural Problem (2506)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/08/2021
Event Type  malfunction  
Manufacturer Narrative
Device history record (dhr) review was conducted, and the product met quality requirements for product acceptance. This device was received for analysis, but the engineering report is not yet available. Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, a 2mm x 30cm x 155cm saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter was inflated but it was noted that the balloon marker was out of position. There was no problem for inflation, so the procedure continued. The device was removed from the patient and it was confirmed the distal marker and the proximal marker were out of position. They were out of position a few millimeters toward the distal side. There was no reported patient injury. The lesion was below the knee. An ipsilateral approach was made. The saber rx pta balloon was used after an unknown guidewire crossed the lesion. The device will be returned for evaluation.
 
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Brand NameSABER RX2MM30CM155
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th avenue
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60th avenue
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60th avenue
miami lakes, FL 33014
7863138372
MDR Report Key12121907
MDR Text Key261217970
Report Number9616099-2021-04682
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 07/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2021
Device Model Number51002030L
Device Catalogue Number51002030L
Device Lot Number82158995
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/04/2018
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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