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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SABER 6MM30CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION SABER 6MM30CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 48006030X
Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/18/2021
Event Type  Injury  
Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, a 6mm x 30cm 150 saber percutaneous transluminal angioplasty (pta) balloon catheter was inflated in its nominal pressure from distal superficial femoral artery (sfa) to popliteal artery when it ruptured separating it completely in half. The proximal part of the saber was removed; however, the distal 17cm was not able to be retrieved. Physician tried numerous attempts, strategies, and devices to remove the remaining balloon. The physician then performed stenting (unknown) from common femoral artery (cfa) to popliteal artery, for assurance of restored flow and patency. Moderate calcification was demonstrated at the burst site. The device was stored as per labeling and opened in a sterile field. The device will be returned for evaluation.
 
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Brand NameSABER 6MM30CM 150
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 Key12380400
MDR Text Key269457493
Report Number9616099-2021-04815
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
Type of Report Initial,Followup,Followup
Report Date 11/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number48006030X
Device Catalogue Number48006030X
Device Lot Number82224519
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/05/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/05/2021
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: 08/27/2021 Patient Sequence Number: 1
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