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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
Catalog Number 48002530X
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/08/2022
Event Type  malfunction  
Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82219401 presented no issues during the manufacturing process that can be related to the reported event. Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, during an inflation to 10 atmospheres (atm), the balloon of a 2. 5mm x 30cm 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter was found to have a leakage. As a result, a 3. 5mm x 30mm saber pta balloon catheter was used in place of the 2. 5mm x 30cm 150cm saber pta balloon catheter to complete the procedure, and there was no reported injury to the patient. This was during an interventional procedure to treat a chronic totally occluded (cto) lesion in the posterior tibial (pt) artery which had calcification and mild tortuosity. The device stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation. There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components and the device was not kinked or damaged in any way prior to being inserted into the patient. A 50-50 contrast and saline mixture was used to prep the balloon and there was no observed leakage during preparation. A non-cordis. 018 guidewire was used for the procedure and was not damaged in any way. There was no difficulty advancing the 2. 5mm x 30cm 150cm saber pta over the unknown guidewire towards the lesion; however, there was some difficulty crossing the lesion. The device was never in an acute bend, was able to be removed easily from the patient, and remained in one piece during removal. General patient information was requested but was not provided and 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 60 avenue
miami lakes, FL 33014
7863138372
MDR Report Key13998806
MDR Text Key290462645
Report Number9616099-2022-05511
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K971010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number48002530X
Device Lot Number82219401
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/18/2021
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: 04/04/2022 Patient Sequence Number: 1
Treatment
3.5MM X 30MM SABER PTA BALLOON CATHETER; IOHEXOL CONTRAST; V-18 GUIDEWIRE, BOSTON SCIENTIFIC
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