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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX6MM4CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION SABER RX6MM4CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number 51006004L
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 6mm x 4cm 155cm saberx percutaneous transluminal angioplasty (pta) balloon catheter ruptured before reaching its nominal burst pressure (nbp) during an inflation of a severely calcified superficial femoral artery (sfa) lesion. As a result, the 6mm x 4cm 155cm saberx pta balloon catheter was removed, and a non-cordis balloon catheter was used to complete the procedure. There was no reported injury to the patient. Additional information was requested but was not provided and the device was discarded and will not be returned.
 
Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82216449 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.
 
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Brand NameSABER RX6MM4CM155
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 Key14192629
MDR Text Key289962961
Report Number9616099-2022-05591
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 05/02/2022
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 Number51006004L
Device Lot Number82216449
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/02/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/30/2021
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: 04/25/2022 Patient Sequence Number: 1
Treatment
UNK BALLOON CATHETER.
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