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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX3MM15CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION SABER RX3MM15CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number 51003015L
Device Problem Burst Container or Vessel (1074)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/31/2022
Event Type  malfunction  
Event Description
As reported, the balloon of a 3mm x 15cm 155cm saberx percutaneous transluminal angioplasty (pta) balloon catheter ruptured during an inflation of a chronic totally occluded (cto) superficial femoral artery (sfa) lesion which showed no signs of tortuosity. There was no reported injury to the patient. The saberx pta balloon catheter was being used with an unknown guidewire when it ruptured. The device was stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation with a 50/50 contrast and saline mixture. 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 experienced during insertion of the balloon catheter. The device was able to track towards the lesion and cross the lesion without issue. The balloon catheter was never put into an acute bend and did not kink during this procedure. After the balloon ruptured, the balloon catheter was able to be removed easily from the patient and remained in one piece during removal. Information regarding the patient, possible presence of calcification at the target site, contrast used, number of atmospheres the device was inflated to, guidewire used, and the completion of the procedure was requested but not provided. The device was discarded and will not be returned.
 
Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
 
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Brand NameSABER RX3MM15CM155
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 Key14192914
MDR Text Key289975336
Report Number9616099-2022-05593
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 05/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number51003015L
Device Lot Number82193103
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/26/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/12/2020
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: 04/25/2022 Patient Sequence Number: 1
Treatment
UNK GUIDEWIRE
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