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U.S. Department of Health and Human Services

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

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COVIDIEN RAPIDCROSS CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number A14BX025080170
Device Problems Difficult to Open or Remove Packaging Material (2922); Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/03/2020
Event Type  malfunction  
Manufacturer Narrative
Product analysis: the rapid cross catheter was returned to medtronic for evaluation within its shelf box. No ancillary devices, cine, images or procedure notes were returned for evaluation. The rapidcross was returned detached in two segments. A proximal segment including the manifold attached and the distal balloon segment terminated at the bond area. The distal balloon segment was detached from the proximal catheter. An inventory of the rapidcross catheter concluded that all components were accounted for. The proximal segment terminated at the proximal wire port and exhibited tensile/torsional stretching. No abnormalities were noted on the balloon chamber. The balloon chamber was observed within its post inflation profile. No abnormalities were noted on the catheter distal tip. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician was using rapidcross pta balloon along with non medtronic 6fr sheath and. 014 guide wire during procedure to treat a little calcified lesion in the right mid posterior tibial artery with chronic total occlusion (cto-100%). The vessel diameter and lesion length were 2. 5mm and 60mm respectively. A non medtronic inflation device was used to inflate the balloon. There was no damage noted to packaging and no issues noted when removing device from hoop/tray. The device was prepped per ifu with no issued identified. It was reported that during removal of the device from the protective packaging, the catheter was twisted at the shaft. Another pta balloon was used to complete the procedure. When the device was received for evaluation it was noted the device was used in the patient. The device was safely removed from the patient. There was no patient injury reported.
 
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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 Key10042161
MDR Text Key193413666
Report Number2183870-2020-00143
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130911
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 05/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberA14BX025080170
Device Catalogue NumberA14BX025080170
Device Lot NumberA885485
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/17/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/21/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/20/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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