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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SABER 2.5MM30CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION SABER 2.5MM30CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 48002530X
Device Problem Material Puncture/Hole (1504)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/28/2020
Event Type  malfunction  
Manufacturer Narrative
This device is not available for testing and evaluation. A review of the manufacturing documentation associated with this lot# 82191505 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, they noticed a hole proximal 5cm before the balloon of a 2. 5mm x 30cm x 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter. They noticed this when they were going to wet it with compression as they always do, so they did not have the unknown wire inside yet. The product was never entered inside the patient. There was no reported patient injury. The product was never used inside the patient. There was no difficulty removing the product from the hoop, from the protective balloon cover or when removing 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. The device was opened in a sterile field. The user was trained with the device. The device will be returned for evaluation.
 
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Brand NameSABER 2.5MM30CM 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 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key10697307
MDR Text Key211894375
Report Number9616099-2020-03988
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeNO
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 11/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number48002530X
Device Catalogue Number48002530X
Device Lot Number82191505
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 Received09/22/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/27/2020
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: 10/19/2020 Patient Sequence Number: 1
Treatment
UNK WIRE
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