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

Catalog Number A14BX030040170

Device Problems Break (1069); Burst Container or Vessel (1074)

Patient Problem Injury (2348)

Event Date 09/26/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician intended to use a rapidcross balloon with a.014 non-medtronic guidewire during treatment a lesion in the distal anterior tibial artery.Moderate tortuosity and calcification are reported.Ifu was followed.It is reported that the balloon broke, and the patient was transferred for surgery to have the broken piece removed.

Manufacturer Narrative

Product analysis: the rapidcross was returned without any ancillary devices.The rapidcross was returned with dried blood throughout the catheter.The catheter shaft detached at the area of the rx port of the catheter.Approximately 7cm of the tip wire was exposed outside of the catheter shaft outer.The distal portion which included the balloon was not returned.The approximate working length of the returned rapidcross was 139cm.A bend to the catheter shaft was noted at approximately 44cm.The area of the catheter separation was observed under microscope.The surface showed rounded edges and separated at the bond area.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.

Manufacturer Narrative

Additional information: a 6fr non-medtronic sheath was used.The pta procedure was being carried out through an existing bypass (bypass was cannulated).The balloon did not break as was previously reported.The shaft of the balloon broke approximately 15-20cm from the distal tip.The patient was 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: 9151159
• MDR Text Key: 165132604
• Report Number: 2183870-2019-00478
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00763000110918
• UDI-Public: 00763000110918
• 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,Followup,Followup,Followup
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2022
• Device Catalogue Number: A14BX030040170
• Device Lot Number: A875729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2019
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Weight: 73