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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 8MM2CM 80 FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CORPORATION POWERFLEXPRO 8MM2CM 80 FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 4400802S
Device Problems Balloon (419); Burst Container or Vessel (1074)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/21/2017
Event Type  Malfunction  
Manufacturer Narrative

The powerflex pro balloon catheter was delivered and inflated; however it ruptured at five (5) to six (6) atmospheres (atm) during its initial inflation. Therefore the powerflex pro was replaced with an unknown 8 mm x 4 cm balloon catheter which was inflated to ten (10) atm and the procedure completed successfully. There was no reported patient injury. An unknown 6f sheath introducer was inserted into the vein of the left forearm and a non cordis guidewire (. 035¿ 150 cm) crossed the lesion. The target lesion was the left brachial vein. The patient¿s vessel level of tortuosity is unknown. The lesion was heavily calcified. The rate of stenosis is unknown. The device prepped normally. There were no difficulties removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components. There were no kinks or other damages noted prior to inserting the product the product into the patient. The product was removed intact (in one piece) from the patient. No other information was provided. The product was not returned for analysis. A device history record (dhr) review of lot 17384269 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. The reported ¿balloon burst-at/below rbp¿ could not be confirmed as the device was not returned for analysis. The exact cause could not be determined. Vessel characteristics of heavy calcification may have contributed to the reported event as calcification may cause damage to a balloon catheter. According to the safety information in the instructions for use ¿if resistance is met during manipulation, determine the cause of the resistance before proceeding. Balloon pressure should not exceed the rated burst pressure. The rated burst pressure is based on the results of in vitro testing. At least 99. 9% of the balloons (with a 95% confidence), will not burst at or below their rated burst pressure. Use of a pressure monitoring device is recommended to prevent over pressurization. Use only the recommended balloon inflation medium. Never use air or any gaseous medium to inflate the balloon. Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used. ¿ neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

 
Event Description

It was reported that the power flex pro balloon catheter was delivered and inflate however, it ruptured at five (5) to six (6) atmosphere (atm) during its initial inflation. Therefore the power flex pro was replaced with an unknown 8 mm*4 cm balloon catheter which was inflated at ten (10) atm and the procedure completed successfully. There was no reported patient injury. An unknown 6f sheath introducer was inserted into the vein of the left forearm and a non cordis guidewire (035*150) crossed the lesion. The target lesion was the left brachial vein. The patient¿s vessel level of tortuosity was unknown. The lesion was heavily calcified. The rate of stenosis was unknown. The device prep normally. There were no difficulties removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components. There were no kinks or other damages noted prior to inserting the product the product into the patient. The product was removed intact (in one piece) from the patient. The product was clinically used and will not be returned for analysis. No other information was provided.

 
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Brand NamePOWERFLEXPRO 8MM2CM 80
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th avenue
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60th avenue
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key6846485
MDR Text Key85146008
Report Number9616099-2017-01400
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK112797
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 09/06/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/06/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2018
Device MODEL Number4400802S
Device Catalogue Number4400802S
Device LOT Number17384269
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date08/22/2017
Event Location No Information
Date Manufacturer Received08/22/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured12/04/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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