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

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.

• Brand Name: RAPIDCROSS
• Type of Device: CATHETER, 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 Key: 8277450
• MDR Text Key: 134090028
• Report Number: 2183870-2019-00032
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00821684067949
• UDI-Public: 00821684067949
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• 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 Received: 01/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/06/2020
• Device Catalogue Number: A14BX040150170
• Device Lot Number: A503859
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2019
• Date Device Manufactured: 08/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention