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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 6MM22CM 80 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION POWERFLEXPRO 6MM22CM 80 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 4400622S
Device Problem Partial Blockage (1065)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/08/2020
Event Type  malfunction  
Manufacturer Narrative
A review of the manufacturing documentation associated with lot (82179728) presented no issues during the manufacturing process that can be related to the reported event. Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, a non-cordis guidewire cannot advanced into the lumen of a 6mm x 22cm x 80cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter till the end. It was completely blocked and was not able to advance. The non-cordis guidewire experienced heavy friction in the catheter lumen approximately at four-fifths (4/5) of the length of the balloon. There was no reported patient injury. The device was stored and handled per the instructions for use (ifu). There were no visible signs of device/package damage prior to use. The device was prepped according to instructions for use (ifu). The device was prep normally. The difficulty was encountered while loading the balloon over the guide wire. There were no visible kinks/bends noted on either one of the devices. The cannula wire port or guidewire lumen was not obstructed. The insertion difficulty was possibly caused by a blockage of injectable material. The difficulty requires that only the reported product was removed. There was excessive torque used during advancement or delivery of the device. When the first resistance was perceived, the surgeon persisted. An extra +- 5cm was achieved, before blocking completely. There were no kink/bent noted after device was removed from patient. The device will be returned for analysis.
 
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Brand NamePOWERFLEXPRO 6MM22CM 80
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th ave
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60th ave
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key10378818
MDR Text Key202020657
Report Number9616099-2020-03833
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K112797
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 10/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4400622S
Device Catalogue Number4400622S
Device Lot Number82179728
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/21/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/07/2020 Patient Sequence Number: 1
Treatment
TERUMO GLIDE WIRE
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