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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX5MM15CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION SABER RX5MM15CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number 51005015L
Device Problem Deflation Problem (1149)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/15/2022
Event Type  Injury  
Event Description
As reported, there was difficulty advancing a 5mm x 15cm 155cm saberx percutaneous transluminal angioplasty (pta) balloon catheter towards a shunt lesion. The device was able to cross the lesion; however, after an inflation to 8 atmospheres (atm), the balloon was unable to be deflated. As a result, the physician pulled the balloon back to a point where an intentional separation of the device could be made in order to deflate the balloon and remove the device. It was reported that none of the device pieces had been left inside of the patient and the procedure was completed after its their removal. This was during a pta procedure to treat a shunt lesion in the axillary vein. The lesion had mild calcification, mild tortuosity, a 99% stenosis, and was not a chronic total occlusion (cto). The device was 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. There was no resistance or friction as the balloon catheter was being inserted into the patient, the device was never in an acute bend, and there were no kinks observed on the device. Information regarding the contrast used, contrast to saline mixture, type of inflation device used, guidewire used was requested but was not provided. Additionally, procedural films were requested but are unavailable. The device will be returned for evaluation.
 
Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82193117 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.
 
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Brand NameSABER RX5MM15CM155
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 Key14100917
MDR Text Key289173023
Report Number9616099-2022-05538
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
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 04/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number51005015L
Device Lot Number82193117
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/25/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/09/2020
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: 04/13/2022 Patient Sequence Number: 1
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