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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 AB18W060100150
Device Problem Burst Container or Vessel (1074)
Patient Problems Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)
Event Date 02/07/2018
Event Type  Injury  
Manufacturer Narrative
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 a severely calcified and slightly tortuous mid left iliac artery lesion exhibiting 100% occlusion. The device was used with a non-mdt sheath <(>&<)> guidewire. No embolic protection was used. The device was removed from its packaging without issue and inspected with no issues noted. The ifu was followed during the procedure. The device did not pass through a previously deployed stent. It was reported that resistance was encountered when advancing the device and that excessive force was used during delivery of the device. During the initial balloon inflation, using a syringe and contrast/saline mix, a balloon burst occurred. Following this, it was reported that a fragment of the balloon remained in the patient. The patient attended the or where the balloon fragment was removed by common femoral endarterectomy. No further patient injury was reported.
 
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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 Key7323289
MDR Text Key101854470
Report Number2183870-2018-00131
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093286
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 03/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/04/2019
Device Catalogue NumberAB18W060100150
Device Lot NumberA384661
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/07/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/05/2016
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: 03/08/2018 Patient Sequence Number: 1
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