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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
Catalog Number A14BX040150170
Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 01/16/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The physician was intending to use a rapidcross to treat a soft tissue lesion in the upper extremity. The device was prepped with no issues. No embolic protection was used. During inflation with a boston scientific inflation device, a balloon burst occurred at nominal atm. The balloon detached from the shaft while retrieving the device through the sheath and the balloon remained in the patient. The patient had surgery to remove the balloon.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Additional information: upon reaching the lesion site, the terumo angled glide 0. 035x260cm wire was removed and replaced with a 0. 014" nitrex guidewire. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Additional information: the physician was intending to use a rapidcross with a 6f 90cm terumo sheath, terumo angled glide wire 0. 035x260cm to treat a soft plaque lesion in the left cephalic vein. Hepsaline contrast was used to inflate the device. Negative prep was not performed, the lesion was not predilated. During first inflation a longitudinal burst occurred. A snare was used to retrieve the bigger balloon portion, the remaining balloon fragments needed to be removed surgically, all balloon fragments were removed from the patient. If information is provided in the future, a supplemental report will be issued.
 
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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 Key8277450
MDR Text Key134090028
Report Number2183870-2019-00032
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,Followup,Followup,Followup
Report Date 04/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/06/2020
Device Catalogue NumberA14BX040150170
Device Lot NumberA503859
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 Received04/09/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/07/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/25/2019 Patient Sequence Number: 1
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