BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER

    MDR report key: 2983244 · Received February 28, 2013

    Report

    Report Number
    9616099-2013-00102
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 28, 2013
    Report Date
    February 8, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LIT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT BECAUSE OF ADDITIONAL INFORMATION RECEIVED, IT WAS REPORTED THAT THE THREE (3) DEVICES/PI'S IN THIS FILE ((B)(4)) WERE USED FOR SEPARATE PATIENT'S/CASES. ALL THREE DEVICES/PI'S WERE ALL READY REPORTED TO THE FDA ON (B)(6) 2013. (B)(4) (PRIMARY PI) PRODUCT 4400704S/LOT # 15717468, MFR #9616099-2013-00102 WILL REMAIN THE SAME. TWO NEW (RELATED) SR'S WERE CREATED TO CAPTURE TWO OF THE DEVICES/PI'S IN THIS FILE. (B)(4) ARE DUPLICATE DEVICES AND WILL BE VOIDED. (B)(4) IS THE DUPLICATE FILE FOR (B)(4) PRODUCT 4400704S/LOT # 15717468 INITIAL MDR/MFR# 9616099-2013-00104 SUBMITTED (B)(6) 2013. THIS PI ((B)(4)) WILL BE VOIDED AS A DUPLICATE FILE. (B)(4) IS THE DUPLICATE FILE FOR (B)(4) PRODUCT 4400704S /LOT # 15705790 INITIAL MDR/MFR # 9616099-2013-00103 SUBMITTED ON (B)(6) 2013. THIS PI ((B)(4)) WILL BE VOIDED AS A DUPLICATE FILE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING THE REVIEW PROCESS, IT WAS NOTED THAT THE COMPLAINT CONCLUSION WAS NOT SUBMITTED WITH THE PREVIOUS MDR REPORT. AS REPORTED BY THE AFFILIATE A POWERFLEX PRO 7MMX4CM 80CM BALLOON CATHETER USED DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF A DIALYSIS SHUNT WAS DIFFICULT TO WITHDRAW THROUGH THE SHEATH. AFTER DEFLATION OF THE DEVICE UNDER VACUUM WITH AN INDEFLATOR, THE BALLOON WAS DIFFICULT TO WITHDRAW THROUGH THE SHEATH REQUIRING THE PHYSICIAN TO USE FORCE. THE PHYSICIAN WAS ABLE TO WITHDRAW THE CATHETER AND THERE WAS NO REPORTED PATIENT INJURY. FAL: ONE NON STERILE CATHETER POWERFLEXPRO 7MM4CM 80 WAS RECEIVED COILED INSIDE A PLASTIC BAG. AN UNKNOWN SHEATH INTRODUCER WAS RECEIVED WITH THE DEVICE. A KINK WAS FOUND IN THE RECEIVED SHEATH INTRODUCER. THE BALLOON WAS PREVIOUSLY INFLATED AND DEFLATED. NO OTHER DAMAGES WERE NOTED. DIMENSIONAL ANALYSIS FOR OD PROXIMAL SEAL WAS PERFORMED USING THE VERNIER AS GO ¿ NO GO AT 1.88 MM, AND THE OD PROXIMAL SEAL WAS FOUND WITHIN SPECIFICATION. THE DIMENSION SPEC OF THE PROXIMAL SEAL OUTER DIAMETER IS = 1.88 MM. AN INSERTION TEST WAS PERFORMED USING THE INVOLVED DEVICES AND THE BALLOON CATHETER WOULD NOT PASS THROUGH THE 5F CSI. A LAB SAMPLE SHEATH INTRODUCER WAS UTILIZED FOR THE TEST AND THE UNIT WAS INSERTED AND WITHDRAWN WITHOUT ANY ANOMALIES NOTED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE REPORTED COMPLAINT OF ¿WITHDRAWAL DIFFICULTY-THROUGH GUIDE/SHEATH¿ WAS CONFIRMED THROUGH ANALYSIS WITH THE UNKNOWN CATHETER SHEATH INTRODUCER WHICH WAS RECEIVED WITH THE RETURNED PRODUCT. HOWEVER, THERE WAS NO RESISTANCE FELT DURING WITHDRAWAL PERFORMED WITH A SAMPLE SHEATH OF THE SAME SIZE DURING ANALYSIS. IT IS NOT POSSIBLE TO DETERMINE AN EXACT CAUSE FOR THE DIFFICULTY EXPERIENCED BY THE CUSTOMER, BUT THE KINK IN THE RECEIVED UNIT MAY HAVE CONTRIBUTED TO THE EVENT. NEITHER THE DHR NOR THE INFORMATION AVAILABLE FOR REVIEW INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    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. THIS IS ONE OF THREE PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT # 9616099-2013-00102, # 9616099-2013-00103, AND # 9616099-2013-00104.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT THE THREE (3 EACH) 80 CM. POWERFLEX PRO 7 MM. X 4 CM. BALLOON CATHETERS USED DURING THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY/PTA OF A DIALYSIS SHUNT TARGET LESION WERE DIFFICULT TO WITHDRAW THROUGH THE SHEATH. IT WAS REPORTED THAT AFTER DEFLATION OF THE DEVICES UNDER VACUUM WITH AN INDEFLATOR, THE BALLOONS BECAME STOCKED PRIOR TO ENTERING THE SHEATH USED. THE PHYSICIAN WAS ABLE TO WITHDRAW THE CATHETERS THROUGH THE SHEATH USING FORCE. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88350 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER PTA CATHETERS LIT CORDIS DE MEXICO NA 15717468

    Patients

    Seq Age Sex Outcome Treatment
    1 TERUMO G/W .035