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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION 2.5X80 CHOCOLATE 150 CM; PTA CATHETERS (LIT)
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CORDIS CORPORATION 2.5X80 CHOCOLATE 150 CM; PTA CATHETERS (LIT) Back to Search Results
Catalog Number CF1415025080OTW
Device Problems Occlusion Within Device (1423); Insufficient Information (3190)
Patient Problems Occlusion (1984); Thrombosis (2100); Thrombus (2101)
Event Date 04/03/2015
Event Type  Injury  
Event Description
As reported, during a percutaneous transluminal angioplasty (pta), the physician inflated the chocolate 2.5 x 80 balloon catheter for fifteen seconds at half nominal pressure and forty-five seconds at nominal pressure.After removal of the device, the vessel was noted to be occluded/have very slow flow.There was no dissection observed.Thrombus was aspirated using an angiojet and additional pta was performed.Flow was restored.There was no reported adverse outcome to the patient.The target lesion was a fem/pop graft to the distal peroneal trunk.The patient was reported to have been anticoagulated.An act was not provided.No additional information was provided.
 
Manufacturer Narrative
The product is not available for evaluation and testing.Additional information will be submitted within 30 days upon receipt.
 
Manufacturer Narrative
Additional information will be submitted within 30 days upon receipt.
 
Manufacturer Narrative
As reported, during a percutaneous transluminal angioplasty (pta), the physician inflated the chocolate 2.5 x 80 balloon catheter for fifteen seconds at half nominal pressure and forty-five seconds at nominal pressure.After removal of the device, the vessel was noted to be occluded/have very slow flow.There was no dissection observed.Thrombus was aspirated using an angiojet and additional pta was performed.Flow was restored.There was no reported adverse outcome to the patient.The target lesion was a fem/pop graft to the distal peroneal trunk.The patient was reported to have been anticoagulated.An act was not provided.No additional information was provided.The product was not returned for inspection.Additionally as the sterile lot number was not available, review of the manufacturing records (dhr) could not be performed.Arterial thrombosis is a known potential adverse event associated with interventional procedures and is listed in the ifu as such.The act of angioplasty produces intended damage to the intima of the vessel wall in order to remodel the wall and reestablish patency of the vessel.The disruption of the intimal layers triggers the immune system to heal the damaged areas, thus activating the clotting mechanism as well as the inflammatory response.The combination of inflammatory response and clotting cascade can lead to thrombus formation.The patient was anticoagulated.There are possible vessel and pharmacological factors that may have contributed to the reported event.Based on the minimal information provided, there is no evidence of manufacturing issues that may have contributed to the reported event; therefore, no corrective action is required at this time.
 
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Brand Name
2.5X80 CHOCOLATE 150 CM
Type of Device
PTA CATHETERS (LIT)
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th avenue
miami lakes FL
Manufacturer Contact
cecil navajas
7060 koll center pkwy
pleasanton, CA 94566
7863133880
MDR Report Key4730065
MDR Text Key5749702
Report Number3008089360-2015-00001
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130414
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Health Professional
Type of Report Initial,Followup,Followup
Report Date 05/21/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberCF1415025080OTW
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/21/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
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