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

Catalog Number A14BX025040170

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/09/2017

Event Type  Injury  

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

A rapidcross pta balloon dilatation catheter was used with a. 014 x 300 non-medtronic guidewire and a 6fr x 90 cm non-medtronic sheath in the right femoral artery and descending aorta to perform an intervention in a patient¿s right radial artery bypass. The balloon was successfully placed over the wire and deployed in the radial bypass. During the removal of the balloon over the wire, it was noted the wire had looped into the descending aorta. An attempt was made to straighten out the loop in the wire by sliding the balloon catheter back and forth. When the catheter was removed, it was found that approximately 30 cm of the balloon catheter with the balloon attached sheared off into the descending aorta. The 6 fr sheath was removed and cut to try and located the missing catheter piece. The sheared piece was located under fluoroscopy by locating the balloon markers and removed with a non-medtronic snare device. The physician examined all equipment to ensure it had been removed entirely from the body. No patient injury was reported.

• 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: 7166535
• MDR Text Key: 101670116
• Report Number: 2183870-2018-00006
• 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: other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/07/2019
• Device Catalogue Number: A14BX025040170
• Device Lot Number: A339722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 09/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/04/2018 Patient Sequence Number: 1