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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN POWERCROSS 018 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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COVIDIEN POWERCROSS 018 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number AB18W040040090
Device Problem Deflation Problem (1149)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 03/20/2018
Event Type  Injury  
Manufacturer Narrative
Evaluation summary: the powercross dilatation catheter was received for evaluation. The powercross dilatation catheter was received loaded within its protective transportation hoop. No ancillary devices, photographic images, or cine images were received for evaluation. The powercross was received in a post inflation profile, (e. G. Not tightly wrapped or winged), sanguine tinted fluid was observed to be in the balloon chamber. Examination of the proximal balloon bond area of the catheter revealed crimp marks from the manufacture procedure pleat and fold in the area of the balloon chamber proximal bond. These crimps would have restricted the inflation lumen <(>&<)> affected the catheter¿s performance to draw a vacuum to evacuate the balloon chamber. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The physician was attempting to use a powercross balloon to treat an arteriovenous fistula(avf). The device was prepped as per the ifu with no issues identified. There was no resistance encountered advancing the device and no excessive force was used. No embolic protection was used. The balloon was inflated using a ac3200 inflation device with 50/50 contrast saline solution. The device was reported to have been inflated to a normal atm pressure with no issues. It was reported the physician was unable to deflate the device and used a needle to puncture the balloon through the skin. The balloon was then removed. There was no damage or kinking noted to the device.
 
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Brand NamePOWERCROSS 018
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key7435614
MDR Text Key105637182
Report Number2183870-2018-00231
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeHK
PMA/PMN Number
K093286
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 04/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/14/2018
Device Catalogue NumberAB18W040040090
Device Lot NumberA243454
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/09/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/20/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/15/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/17/2018 Patient Sequence Number: 1
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