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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SABER035 6MM30CM 135 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION SABER035 6MM30CM 135 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 48006030R
Device Problem Burst Container or Vessel (1074)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/10/2022
Event Type  malfunction  
Event Description
As reported, the balloon of a saber. 035 6mm 30cm 135 ruptured at 8 atm while in a in-stent restenosis. The procedure was completed after the use of a new saber 035 6mm x 200mm balloon catheter. There was no reported injury to the patient. It was noted that this balloon is part of a pre-market trial. The product was stored per the instructions for use (ifu). There was no difficulty removing the device from the hoop, removing the protective balloon cover, or removing the stylet/sterile packaging components. There were no kinks or other damages noted prior to inserting the product into the patient. The device was prepped per the ifu and was prepped normally. The device was able to maintain negative pressure. The lesion was in the right superficial femoral artery. A contralateral approach was made from the left femoral artery. The lesion was noted to have moderate-severe calcification. The vessel did not have any tortuosity. The lesion had an 80% stenosis. There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or while inserting the balloon though the unknown guide catheter. The catheter advanced through the vessel and lesion without difficulty. The non-cordis inflation device was filled with a 50/50 contrast/saline ratio. That inflation device was used successfully with other devices in the case. The catheter was never in an acute bend. The catheter was never kinked while being used. The device was removed intact (in one piece) from the patient. The device will be returned for evaluation.
 
Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt. This device is available for analysis, but the engineering report is not yet available. However, it will be submitted within 30 days upon receipt.
 
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Brand NameSABER035 6MM30CM 135
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 Key13999926
MDR Text Key298296756
Report Number3007635982-2022-00004
Device Sequence Number1
Product Code LIT
UDI-Device Identifier20705032080245
UDI-Public(01)20705032080245(17)240930(10)82235914
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number48006030R
Device Catalogue Number48006030R
Device Lot Number82235914
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/16/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/22/2021
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: 04/04/2022 Patient Sequence Number: 1
Treatment
BARD INFLATION DEVICE WITH OMNIPAQUE; SABER 035 6MM X 200MM BALLOON CATHETER; UNK STENT (PREVIOUSLY PLACED)
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