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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SABER 2MM2CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION SABER 2MM2CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 48002002X
Device Problems Partial Blockage (1065); Difficult to Advance (2920); Material Integrity Problem (2978)
Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/21/2022
Event Type  malfunction  
Manufacturer Narrative
The product history review is expected but has not been completed. 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, while performing preconditioning testing for saber over the wire (otw), an obstruction of foreign material was found inside of the guidewire lumen of a 2mm x 2cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter. As mentioned, this was during preconditioning testing of the device and there was no patient involvement or clinical use of the device. The sample was successfully flushed; however, during the guidewire insertion portion of the sample prep, the guidewire failed to pass through the lumen and out of the hub. Upon review of the device, an obstruction was seen in the lumen near the hub. An inflation device with filtered water was then used to flush the injection lumen. I was reported that 30 atmospheres (atm) of pressure was required to dislodge the obstructing material from the balloon catheter. The device along with the obstructing material was sent to the analytical lab for further analysis.
 
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Brand NameSABER 2MM2CM 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 Key13904804
MDR Text Key290463093
Report Number9616099-2022-05487
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 Other,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 04/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number48002002X
Device Catalogue Number48002002X
Device Lot Number82230564
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/17/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/25/2022 Patient Sequence Number: 1
Treatment
UNK GUIDEWIRE
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