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

Catalog Number	A14BX040150170
Medical Device Problem Codes	Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	01/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional 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.
Additional 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
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 8277450
• Report Number: 2183870-2019-00032
• Device Sequence Number: 11138096
• Product Code: LIT
• UDI-Device Identifier: 00821684067949
• UDI-Public: 00821684067949
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K082854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/06/2020
• Device Catalogue Number: A14BX040150170
• Device Lot Number: A503859
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/18/2019
• Supplement Date Received by Manufacturer: 01/29/2019; 03/28/2019; 04/09/2019
• Initial Report FDA Received Date: 01/25/2019
• Supplement Report FDA Received Date: 02/18/2019; 03/29/2019; 04/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention