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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
Model Number AB14W020100150
Device Problems Inflation Problem (1310); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/16/2021
Event Type  malfunction  
Manufacturer Narrative
Image review: the customer sent one image. The image shows twisting to the proximal end of the balloon. Product analysis: the device returned loosely coiled inside a shelf carton and inside two biohazard bags. Lot number on shelf carton label: b221202. The device was decontaminated with cidex opa solution soak. A visual inspection of the device found a twist on the proximal end of the balloon. A 20ml water filled syringe was used to flush the device and a steady stream of water was observed exiting the tip. A 0. 014¿ guidewire was loaded through the tip and exited the hub without any difficulty. An indeflator with pressure gauge was used to inflate the balloon to 8 atm and 14 atm but the balloon would not inflate. There was evidence of hardened contrast in the shaft of the device, and this is the most likely reason that the balloon will not inflate. The device was left in warm water overnight in an attempt to soften the contrast, but this was unsuccessful. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician attempted to use a nanocross elite pta balloon with a 6fr non-medtronic sheath and a 0. 014 non-medtronic guidewire during treatment of a 120mm fibrous lesion in the patient¿s mid anterior tibial artery. Little vessel tortuosity and little calcification are reported. Artery diameter reported as 2mm. No embolic protection was used. There was no damage noted to packaging, i. E. Shelf carton, hoop/tray. No issues were noted when removing the device from the hoop/tray. Ifu was followed and the device was prepped without issue. A non-medtronic inflation device was used. 50/50 inflation fluid was used. The balloon was not passed through a previously deployed stent. No resistance was noted during advancement of the device. It is reported balloon inflation difficulties occurred at an inflation pressure of 8atm. Balloon just did not inflate properly, very proximal and very small portion of the balloon inflated and the rest of the balloon did not. There was no leaks noted. No intervention was required to remove the device. The device was safely removed from the patient. A new balloon was used to complete the procedure. No patient injury reported. A twist was noted on the proximal end of the returned balloon.
 
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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
MDR Report Key12751579
MDR Text Key280120801
Report Number2183870-2021-00400
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K082854
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial
Report Date 11/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAB14W020100150
Device Catalogue NumberAB14W020100150
Device Lot NumberB221202
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/15/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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