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

Catalog Number A14BX020020170

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/01/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The physician intended to use a rapidcross to treat a 150mm soft tissue lesion with 90% stenosis in the left proximal anterior tibial artery, diameter of artery 2mm. A 4/5 slender terumo medical sheath and a 0. 014 lake region medical guidewire was used. There was no damage to the packaging or to the device when removing from hoop/tray. The device was prepped with no issues. No embolic protection was used. The device passed through a previously deployed stent. No resistance was encountered during advancement of the device and no excessive force used. It was reported that wire movement issues occurred, and the guidewire locked up during the procedure. The physician pulled the guidewire lumen with resistance and was unable to remove the device from the guidewire. The wire was removed from the patient and a pressure dressing applied. The rapidcross was inflated to 8atms with a boston scientific inflation device using 1:1 contrast/saline. The balloon detached during removal from the patient while pulling the device out of the sheath. When the catheter was removed the physician noticed that the balloon catheter segment was not attached. X-ray fluoroscopy located the radio opaque markers and identified the balloon with some wire at the level of the left auxiliary artery near the subclavian. As the physician attempted to recover the detached segment the patient coded and was transferred to the emergency room at another facility. The detached portion remains in the patient.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: a cut down surgical procedure was conducted. The detached portion of the balloon was removed from the patient. The patient is reported as stable and has been discharged from hospital. 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: 8331512
• MDR Text Key: 135884351
• Report Number: 2183870-2019-00069
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/22/2020
• Device Catalogue Number: A14BX020020170
• Device Lot Number: A480801
• 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 Received: 05/09/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 06/23/2017
• 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: 02/12/2019 Patient Sequence Number: 1