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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SABER 3MM6CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION SABER 3MM6CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number N/A
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/10/2021
Event Type  malfunction  
Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82208972 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, as the tip of the 3mm x 6cm x 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter (bc) was advanced over the guidewire (unknown), the tip separated and fell. There was no reported patient injury. The device cannot be used for the patient. There was no damage to the device noticed prior to opening the package. There was no difficulty removing the device from the sterile packaging. The device was stored and prepped per the instructions for use (ifu). The patient had no infectious disease. The device is expected to be returned for analysis.
 
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Brand NameSABER 3MM6CM 150
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 Key12120022
MDR Text Key260041412
Report Number9616099-2021-04679
Device Sequence Number1
Product Code LIT
UDI-Device Identifier20705032069325
UDI-Public20705032069325
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K971010
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 08/03/2021
1 Device was Involved in the Event
1 Patient was 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 Model NumberN/A
Device Catalogue Number48003006X
Device Lot Number82208972
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/24/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/30/2020
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: 07/06/2021 Patient Sequence Number: 1
Treatment
SABER BALLOON; UNKNOWN GUIDEWIRE
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