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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SABER 6MM10CM 90 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION SABER 6MM10CM 90 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 48006010S
Device Problem Deflation Problem (1149)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/25/2022
Event Type  Injury  
Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82221990 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 saber 6mm 10cm 90 would not deflate in the sfa; therefore, the doctor had to use a long needle to burst the pta. Ultrasound was used to locate the pta, and then placed a needle though the thigh to deflate the balloon. The doctor used another saber pta 6x10x90 balloon and it worked fine and case was completed. The patient was ok and there was no reported injury. An attempt was made to deflate the balloon by cutting the shaft, it was unsuccessful. The device was stored per the instructions for use (ifu). There was no difficulty removing the product from the hoop, removing the protective balloon cover, or removing 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 able to maintain negative pressure. The device was being used to post dilate a stent. The lesion was noted to have little calcification with no vessel tortuosity. The lesion had a 90% stenosis prior to stenting. It was not being used to treat a chronic total occlusion. The non-cordis inflation device was filled with an 80/20 contrast/saline ratio. There was no resistance/friction noted while the balloon catheter was inserted through the rotating hemostatic valve or guide catheter. The catheter was advanced through the vessel without difficulty. There was no difficulty crossing the lesion. The catheter was never in an acute bend. The catheter never kinked while being used. The device was removed intact (in one piece) from the patient. The device will be returned for evaluation.
 
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Brand NameSABER 6MM10CM 90
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 Key13896502
MDR Text Key292027442
Report Number9616099-2022-05484
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K971010
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,Followup
Report Date 04/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number48006010S
Device Catalogue Number48006010S
Device Lot Number82221990
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/04/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/08/2021
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/24/2022 Patient Sequence Number: 1
Treatment
SABER PTA; UNK NEEDLE
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