• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN RAPIDCROSS CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COVIDIEN RAPIDCROSS CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Intimal Dissection (1333); Occlusion (1984)
Event Date 11/14/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported in the literature article, usefulness of the ¿non-slip element¿ percutaneous transluminal angioplasty balloon in the treatment of femoropopliteal arterial lesions, that a study was carried out to evaluate a new scoring balloon, the non-slip element (nse) percutaneous transluminal angioplasty (pta) balloon, in the treatment of femoropopliteal lesions by comparing angiographic dissection patterns to those of a conventional balloon over a 17 months period. This retrospective, single-centre study included 71 symptomatic patients with de novo femoropopliteal lesions <(><<)>20 cm long treated with balloon angioplasty. Thirty-four patients were treated with 3 inflations of an nse balloon and 37 patients were treated with a conventional balloon. In the 37 non-nse patients, angioplasty was performed on 3 patients using a conventional rapidcross balloon and the other 34 patients non-medtronic conventional balloons were used. Severe dissections were fewer and the total dissection length was shorter in the nse group. The bailout stenting rate was also lower in the nse group. There were no significant differences between the groups regarding lesion length, inflation time, or inflation pressure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRAPIDCROSS
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 Key9799976
MDR Text Key196385918
Report Number2183870-2020-00072
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K130911
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received05/11/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/06/2020 Patient Sequence Number: 1
-
-