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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, TRANSLUMINAL

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COVIDIEN NANOCROSS 0.14 OTW PTA DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number AB14W020040150
Device Problems Burst Container or Vessel ; Kinked
Event Date 12/30/2016
Event Type  Malfunction  
Event Description

Amphirion deep pta balloon was deployed in mid-distal peroneal artery with stenosis (calcification) present and inflated to 7atm (nominal) on first inflation at lesion. However, the balloon was unable to maintain its constant pressure as shown on the inflation device where the pressure kept dropping. A second inflation attempt was done but likewise, the balloon was unable to maintain at nominal pressure. Physician suspected that there could be a leak in the balloon. As there was still a focal calcified stenosis present in the distal peroneal artery after the amphirion deep pta balloon inflations, physician decided to deploy a nanocross pta balloon for focal treatment and inflated it to 10atm (nominal) on first inflation at lesion. However, the balloon was unable to maintain its constant pressure as shown on the inflation device where the pressure kept dropping. A second inflation attempt was done but likewise, the balloon was unable to maintain at nominal pressure. Physician suspected that there could be a leak in the balloon as well. The lesion was moderately calcified which exhibited 80% - 85% stenosis, vessel was non-tortuous. The lesion diameter is 2. 0mm and lesion length 120mm. There was no injury to patient. Lesion was treated with a competitor product (ie. Abbott¿s armada 14 pta balloon).

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Manufacturer Narrative

Evaluation summary: the nanocross device was returned inside a clear re-sealable bag. The nanocross was inspected and noted dried white residue within the balloon segment. Within the balloon segment buckling of the catheter was noted approximately 0. 75 cm from the tip. A kink to the catheter shaft was noted approximately 47m from the tip. The balloon was inspected under microscope and was unable to identify any holes or tears to the balloon material. A guidewire could not be loaded due to the buckling noted to the catheter within the balloon segment. An inflation device filled with water was able to inflate the balloon and hold pressure at 12 atm for 5 minutes. No leaks were detected. The nanocross was next administered with 18 atm pressure for 5 minutes and no leaks detected. The inflated catheter was submerged and soaked in water for 24 hours. No leak from the balloon was detected, however the dried residue dissolved. The buc kling proximal to the distal marker band was more visible/clear. If information is provided in the future, a supplemental report will be issued.

 
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Brand NameNANOCROSS 0.14 OTW PTA DILATATION CATHETER
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
COVIDIEN
4600 nathan lane
plymouth MN 55442
Manufacturer (Section G)
COVIDIEN
4600 nathan lane
plymouth MN 55442
Manufacturer Contact
toni o'doherty
parkmore business park west
galway  
091708734
MDR Report Key6292159
Report Number2183870-2017-00045
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/03/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/01/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/07/2017
Device MODEL NumberAB14W020040150
Device Catalogue NumberAB14W020040150
Device LOT NumberA117900
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/21/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/10/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/08/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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