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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX4MM15CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION SABER RX4MM15CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 51004015L
Device Problem Burst Container or Vessel (1074)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/04/2022
Event Type  malfunction  
Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, the balloon of a saber rx 4mm 15cm 155 ruptured after passing the nominal pressure 8 atm, it ruptured at approximately 10 to 12 atm; therefore, it was replaced with a new saberx (4mm*10cm) and it could be inflated 14 atm and the case was completed. There was no reported injury to the patient. The product was stored properly according to the instructions for use (ifu). There was no difficulty removing the device from the hoop. There was no difficulty noted while removing the protective balloon cover, stylet, or any of the sterile packaging components. There were no kinks or other damages noted on the device prior to inserting into the patient. The device was prepped per the ifu and was able to maintain negative pressure. The lesion was the left superficial femoral artery, popliteal artery to back-knee with stenosis and occlusion. An approach was made from the right femoral artery with a non-cordis 6f guiding sheath. A non-cordis. 018 guidewire crossed the lesion. The lesion was noted to have moderate to severe calcification. The vessel had moderate tortuosity. The lesion had a 80%-100% stenosis. The device was being used to treat a chronic total occlusion (cto). A saberx (3mm*4cm) was inflated at the superficial femoral artery to the popliteal artery. After that, the saber rx 4mm 15cm 155 was used. It crossed the lesion and inflated the ruptured. The non-cordis inflation device was filled with visipaque. The contrast/saline ratio was unknown. The inflation device was used successfully with other devices during the case. A y-connector was used for inserting the balloon catheter. The balloon catheter was never in an acute bend and was never kinked while being used. The device was removed without any issues. The device was discarded and will not be returned.
 
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Brand NameSABER RX4MM15CM155
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 Key13953922
MDR Text Key290462596
Report Number9616099-2022-05493
Device Sequence Number1
Product Code LIT
UDI-Device Identifier20705032075913
UDI-Public(01)20705032075913(17)240731(10)82230538
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 04/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number51004015L
Device Catalogue Number51004015L
Device Lot Number82230538
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/02/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/23/2021
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: 03/30/2022 Patient Sequence Number: 1
Treatment
GUIDEWIRE (0.018 VASSALLO, ASAHIINTECC); INFLATION DEVICE: GM30, NIPRO; PARENT GUIDING SHEATH (6F); SABERX (3MM*4CM), SABERX (4MM*10CM)
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