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

Catalog Number	A14BX025040170
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	11/09/2017
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
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.
Additional Manufacturer Narrative
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: 7166535
• Report Number: 2183870-2018-00006
• Device Sequence Number: 13928999
• Product Code: LIT
• UDI-Device Identifier: 00821684067369
• UDI-Public: 00821684067369
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K130911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2018

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: 09/07/2019
• Device Catalogue Number: A14BX025040170
• Device Lot Number: A339722
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/06/2017
• Supplement Date Received by Manufacturer: 01/05/2018
• Initial Report FDA Received Date: 01/04/2018
• Supplement Report FDA Received Date: 02/02/2018
• 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
• Patient Age: 59 YR