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

Model Number A14BX025080170

Device Problems Difficult to Open or Remove Packaging Material (2922); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the rapid cross catheter was returned to medtronic for evaluation within its shelf box.No ancillary devices, cine, images or procedure notes were returned for evaluation.The rapidcross was returned detached in two segments.A proximal segment including the manifold attached and the distal balloon segment terminated at the bond area.The distal balloon segment was detached from the proximal catheter.An inventory of the rapidcross catheter concluded that all components were accounted for.The proximal segment terminated at the proximal wire port and exhibited tensile/torsional stretching.No abnormalities were noted on the balloon chamber.The balloon chamber was observed within its post inflation profile.No abnormalities were noted on the catheter distal tip.If information is provided in the future, a supplemental report will be issued.

Event Description

Physician was using rapidcross pta balloon along with non medtronic 6fr sheath and.014 guide wire during procedure to treat a little calcified lesion in the right mid posterior tibial artery with chronic total occlusion (cto-100%).The vessel diameter and lesion length were 2.5mm and 60mm respectively.A non medtronic inflation device was used to inflate the balloon.There was no damage noted to packaging and no issues noted when removing device from hoop/tray.The device was prepped per ifu with no issued identified.It was reported that during removal of the device from the protective packaging, the catheter was twisted at the shaft.Another pta balloon was used to complete the procedure.When the device was received for evaluation it was noted the device was used in the patient.The device was safely removed from the patient.There was no patient injury 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 ; IE ; 091708734
• MDR Report Key: 10042161
• MDR Text Key: 193413666
• Report Number: 2183870-2020-00143
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00763000110796
• UDI-Public: 00763000110796
• 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: Physician
• Type of Report: Initial
• Report Date: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2022
• Device Model Number: A14BX025080170
• Device Catalogue Number: A14BX025080170
• Device Lot Number: A885485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2019
• 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 Age: 73 YR