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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS DE MEXICO POWERFLEXPRO 5MM15CM 135 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS DE MEXICO POWERFLEXPRO 5MM15CM 135 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 4400515X
Device Problems Material Frayed; Torn Material; Catheter; Tip
Event Date 01/11/2017
Event Type  Malfunction  
Manufacturer Narrative

Manufacturing record (dhr) review was conducted and the product met quality requirements for product acceptance per the applicable manufacturing quality plan.   the product is available for evaluation and testing. However, the product has not been returned as of to date. Additional information will be submitted within 30 days upon receipt.

 
Event Description

As reported, during an interventional procedure, while attempting to pot-dilate a smart 6 mm. Stent, the 135 cm. Powerflexpro 5 mm. X 15 cm. Balloon catheter became stuck on the stent during advancement. The product was successfully removed from the patient. Upon inspection after removal, the distal tip was noted to be frayed. The procedure completed successfully although the details were unknown. There was no reported patient injury. The product was clinically used and it will be returned for analysis. The target lesion was unknown. No target lesion characteristic information was available.

 
Manufacturer Narrative

Additional information received indicated that the product will not be returned for inspection. Event description updated.   during an interventional procedure, while attempting to post-dilate a smart 6 mm. Stent, the 135 cm. Powerflex pro 5 mm. X 15 cm. Balloon catheter became stuck on the stent during advancement. The product was successfully removed from the patient. Upon inspection after removal, the distal tip was noted to be frayed. The procedure completed successfully although the details were unknown. There was no reported patient injury. The target lesion was unknown. No target lesion characteristic information was not available. Additional information received indicated that the powerflex pro (complaint product) was removed intact from the patient. The product was stored properly according to the instructions for use (ifu). There was no damage noted to the product packaging upon inspection prior to use. There was no reported difficulty removing the product from the packaging. The product was inspected prior to use and appeared to be normal. The product was prepped properly according to the ifu. Additional information was requested but was reported to be unknown. No additional information is available. The product was not returned for analysis. A device history record (dhr) review of lot 17417368 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. The reported ¿pta/ptca system tracking difficulty - through stent¿ and ¿distal tip frayed/split/torn - in-patient¿ could not be confirmed as the device was not returned for analysis. The exact cause could not be determined. Procedural factors may have contributed to the reported event as the event description states the ¿balloon catheter became stuck on the stent during advancement¿. According to 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 limited 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

As reported, during an interventional procedure, while attempting to pot-dilate a smart 6 mm. Stent, the 135 cm. Powerflexpro 5 mm. X 15 cm. Balloon catheter became stuck on the stent during advancement. The product was successfully removed from the patient. Upon inspection after removal, the distal tip was noted to be frayed. The procedure completed successfully although the details were unknown. There was no reported patient injury. The product was clinically used and it will not be returned for analysis. The target lesion was unknown. No target lesion characteristic information was available. Additional information received indicated that the powerflexpro (complaint product) was removed intact from the patient. The product was stored properly according to the instructions for use (ifu). There was no damage noted to the product packaging upon inspection prior to use. There was no reported difficulty removing the product from the packaging. The product was inspected prior to use and appeared to be normal. The product was prepped properly according to the ifu. Additional information was requested but was reported to be unknown. No additional information is available.

 
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Brand NamePOWERFLEXPRO 5MM15CM 135
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS DE MEXICO
circuito int nte 1820
juarez 32575
MX  32575
Manufacturer (Section G)
CORDIS DE MEXICO
circuito int nte 1820
juarez 32575
MX  32575
Manufacturer Contact
cecil navajas
14201 nw 60th ave.
miami lakes , FL 33014
MDR Report Key6298204
Report Number9616099-2017-00890
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 02/16/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/02/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2019
Device MODEL Number4400515X
Device Catalogue Number4400515X
Device LOT Number17417368
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date01/12/2017
Event Location No Information
Date Manufacturer Received02/16/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured03/01/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/02/2017 Patient Sequence Number: 1
Treatment
SMART 6 MM. STENT
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