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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN NANOCROSS 0.14 OTW PTA DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

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COVIDIEN NANOCROSS 0.14 OTW PTA DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
Catalog Number AB14W040150090
Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/29/2021
Event Type  malfunction  
Manufacturer Narrative
Device evaluation the device returned detached with the balloon portion detached at approx. 13cm proximal from the distal tip. The balloon returned bunched and kinked. The detachment on the inner shaft is approx. 70. 5cm distal from the strain relief and the outer shaft detached approx. 71. 5cm distal from the strain relief. A kink on the catheter shaft is noted at approx. 2. 5cm distal from the strain relief. The detachment sites are visible under a microscope with frayed edges. Bunching is visible along the full length of the balloon with some bunching and kinks visible on the catheter shaft. Functional testing could not be performed due to the condition of the returned device. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician was attempting to use a nanocross pta balloon along with 6fr sheath, spider fx guidewire and 7. 0 spider fx embolic protection. During procedure to treat a severely calcified plaque lesion in the mid superficial femoral artery (sfa) with 90% stenosis. The vessel was little tortuous. A non-medtronic inflation device was used. There was no damage noted to packaging. There was no issue noted when removing device from hoop/tray. The balloon inflated successfully in the patient once. It was reported that removal difficulty occurred during removal of balloon through sheath and off wire. There was difficulty removing balloon following balloon inflation. Physician was able to remove off of wire, no snare or surgery necessary. Detachment was noted during removal, but only after the balloon was removed from the sheath and the entire balloon and catheter were outside of the patient's body. The balloon component detached from the catheter. The device did not pass through a previously deployed stent. There was no resistance encountered when advancing the device but excessive force was used during withdrawal. The balloon was removed safely from the patient and an identical balloon (including lot/batch number) was opened and used without issue. There was no vessel damage noted. There was no patient injury.
 
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Brand NameNANOCROSS 0.14 OTW PTA DILATATION CATHETER
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
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 
EI  
091708734
MDR Report Key12574825
MDR Text Key274752585
Report Number2183870-2021-00368
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082854
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 10/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/15/2022
Device Catalogue NumberAB14W040150090
Device Lot NumberA768064
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/17/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/22/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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