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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER PTA CATHETERS (LIT)

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CORDIS CORPORATION POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER PTA CATHETERS (LIT) Back to Search Results
Catalog Number 4400608X
Device Problems Partial Blockage; Catheter
Event Date 07/22/2015
Event Type  Malfunction  
Manufacturer Narrative

(b)(6). A review of the manufacturing documentation associated with this lot 17088796 was performed and the following was found: review of lot 17088796 revealed no anomalies during the manufacturing and inspection processes. The product was returned for evaluation and testing; however, the engineering evaluation is not complete. Additional information will be submitted within 30 days upon receipt.

 
Event Description

As reported, the "telmo" guide wire could not pass through the middle portion of the 135 cm. Powerflexpro 6 mm. X 8 cm. Balloon catheter (bc) guidewire lumen during preparation for the procedure. There was a blockage or clot suspected in the lumen of the balloon catheter. The balloon was exchanged for another device and used with the same wire to successfully complete the procedure. There was no report of patient injury as the product was not used in the patient. The product will be returned for evaluation, however, the wire will not be returned. There was no damage noted to the product packaging upon inspection prior to use and there was no reported difficulty removing the product from the packaging. The product and wire was inspected prior to use and appeared to be normal. The product was prepped properly according to the instructions for use (ifu) and there was no problem reported flushing the device. The device was flushed prior to use and before trying to load the device onto the guide wire. There was no other product issue noted either at the account after the procedure or prior to shipping for inspection. No additional information is available including target lesion information.

 
Manufacturer Narrative

The guide wire could not pass through the middle portion of the 135 cm. Powerflex pro 6 mm. X 8 cm. Balloon catheter (bc) guidewire lumen during preparation for the procedure. There was a blockage or clot suspected in the lumen of the balloon catheter. The balloon was exchanged for another device and used with the same wire to successfully complete the procedure. There was no report of patient injury as the product was not used in the patient. There was no damage noted to the product packaging upon inspection prior to use and there was no reported difficulty removing the product from the packaging. The product and wire was inspected prior to use and appeared to be normal. The product was prepped properly according to the instructions for use (ifu) and there was no problem reported flushing the device. The device was flushed prior to use and before trying to load the device onto the guide wire. There was no other product issue noted either at the account after the procedure or prior to shipping for inspection. No additional information is available including target lesion information. The product was returned for analysis. A non-sterile unit of powerflex pro 6mmx8cm 135cm bc was returned. Per visual analysis no damages were observed on the unit and the balloon had not been inflated. Per functional analysis a 0. 035¿ guide wire (lab sample) was inserted into balloon catheter and the guide wire passed through the catheter without difficulty. Per microscopic analysis no damages were observed. Cross sectional analysis was not required as damages were not observed on the device and the functional test was performed successfully. A device history record (dhr) review of lot 17088796 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. The reported ¿guidewire lumen/obstructed: particles can be/were injected (peripheral)¿ was not confirmed by analysis of the returned device. The exact cause of the reported event could not be confirmed. The device performed as intended and therefore could not be related to the manufacturing process; therefore, no corrective/preventive action will be taken.

 
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Brand NamePOWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
Type of DevicePTA CATHETERS (LIT)
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th avenue
miami lakes FL
Manufacturer Contact
cecil navajas
circuito interior norte #1820
juarez chihuahua  32580
  32580
7863133880
MDR Report Key5114698
Report Number9616099-2015-00475
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 09/07/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/30/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2017
Device Catalogue Number4400608X
Device LOT Number17088796
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/21/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/12/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/08/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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