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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX7MM4CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION SABER RX7MM4CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number 51007004L
Device Problem Burst Container or Vessel (1074)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/04/2022
Event Type  malfunction  
Event Description
As reported, the balloon of a 7mm x 4cm 155cm saberx percutaneous transluminal angioplasty (pta) balloon catheter ruptured during an inflation of 2 atmospheres (atm). As a result, the 7mm x 4cm 155cm saberx pta was removed, and a 7mm x 4cm non-cordis balloon catheter was inserted and successfully inflated to complete the procedure. There was no reported injury to the patient. This was during an interventional procedure to treat a moderately calcified, 90 % stenosed lesion in the external iliac artery. There were no signs of tortuosity or chronic total occlusion (cto) present at the target site. The device was stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation. Iomeprol contrast was used for the procedure to prep the 7mm x 4cm 155cm saberx pta balloon catheter and the contrast to saline ratio was 1:1. 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 difficulty crossing the lesion; however, the balloon catheter was put in an acute bend during the procedure. After the balloon ruptured, the device was able to be removed easily and remained in one piece during removal from the patient. The device was discarded and will not be returned for evaluation.
 
Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
 
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Brand NameSABER RX7MM4CM155
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 Key13981320
MDR Text Key290462660
Report Number9616099-2022-05503
Device Sequence Number1
Product Code LIT
UDI-Device Identifier20705032075364
UDI-Public(01)20705032075364(17)240531(10)82219758
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 04/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number51007004L
Device Lot Number82219758
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/04/2021
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: 04/01/2022 Patient Sequence Number: 1
Treatment
7MM X 4CM BALLOON (BOSTON SCIENTIFIC); IOMEPROL CONTRAST
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