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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SABER 2.5MM25CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION SABER 2.5MM25CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 48002525X
Device Problem Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/09/2021
Event Type  malfunction  
Event Description
During use, the saber 2. 5mm x 25cm balloon catheter and balloon were punctured by the wire when loading it over the wire. There was no patient injury. The device was prepped per the instruction for use (ifu) and there were no difficulty noted in the balloon during prep. There were no difficulties removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components. There were no kinks or other damages noted prior to inserting the product the product into the patient. Femoral retrograde access was made. The balloon was discarded and will not be returned for analysis. No other information was provided.
 
Manufacturer Narrative
This device is not available for testing and evaluation. Additional information is pending and will be submitted within 30 days upon receipt.
 
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Brand NameSABER 2.5MM25CM 150
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 Key12960439
MDR Text Key286062572
Report Number9616099-2021-05139
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K971010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number48002525X
Device Catalogue Number48002525X
Device Lot Number82226769
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/22/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/08/2021 Patient Sequence Number: 1
Treatment
UNK WIRE.
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