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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX6MM6CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION SABER RX6MM6CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number 51006006L
Device Problem Burst Container or Vessel (1074)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/14/2022
Event Type  malfunction  
Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82234583 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, the balloon of a 6mm x 6cm 155cm saberx percutaneous transluminal angioplasty (pta) balloon catheter ruptured during an inflation to 14 atmospheres (atm). As a result, the 6mm x 6cm 155cm saberx pta balloon catheter was removed and a 6mm x 4cm saberx pta balloon catheter was used and successfully inflated to 16 atm without difficulty. This was followed by the use of 7mm x 6cm non-cordis balloon catheter to complete the procedure. There was no reported injury to the patient. This was during a procedure to treat a 90-95% stenosed lesion in the right superficial femoral artery (sfa) in which a 6f 45cm non-cordis guiding sheath was used to access the right inguinal region. The lesion had moderate to severe calcification, moderate tortuosity, and was not a chronic total occlusion (cto). The device was stored and prepped per the instructions for use (ifu). There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components. There was no resistance or friction experienced as the device was being inserted and a non-cordis. 014 guidewire was used to successfully to cross the lesion. There were no issues reported during the removal of the 6mm x 6cm 155cm saberx pta balloon catheter post rupture, and the device remained in one piece during removal. Information regarding the patient, preparation of the balloon, contrast used, contrast to saline ratio, device tracking difficulty, and possible difficulty crossing the lesion was requested but not provided, and the device was discarded and will not be returned for evaluation.
 
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Brand NameSABER RX6MM6CM155
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 Key14054369
MDR Text Key288902813
Report Number9616099-2022-05530
Device Sequence Number1
Product Code LIT
UDI-Device Identifier20705032076118
UDI-Public(01)20705032076118(17)240930(10)82234583
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 04/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number51006006L
Device Lot Number82234583
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/13/2021
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: 04/08/2022 Patient Sequence Number: 1
Treatment
(7¿*6¿ RANGERDC, BOSTON SCIENTIFIC); 6F 45CM CROSSROAD NIPRO GUIDING SHEATH; 6MM X 4CM SABERX PTA BALLOON CATHETER; GUIDEWIRE (0.014 VASSALLO, ASAHIINTECC)
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