MAUDE Adverse Event Report: SUPERDIMENSION INC. EDGE CATHETER SYSTEM; GUIDE CATHETER

Model Number SD90EWCTE EDGE 90 EWC

Device Problem Bent (1059)

Patient Problems Bradycardia (1751); Hemorrhage/Bleeding (1888); Low Oxygen Saturation (2477)

Event Date 12/08/2015

Event Type  Injury  

Manufacturer Narrative

A component of the superdimension system, extended working channel, was returned and evaluated.The catheter was found to have an extra bend and had scuffing on the outside of the catheter body.A nick in the catheter was also discovered.It is unknown how this damage occurred and it cannot be determined if this damage contributed to the reported event.No additional components were returned for evaluation.There were no anomalies identified during the internal review of the dhr of the system console and ewc.Bleeding is a known short term complication when a lung biopsy is performed during a transbronchial lung biopsy or ct guided percutaneous biopsy.If additional information pertinent to the incident is obtained a follow-up report will be submitted.

Event Description

The patient experienced extreme bleeding resulting in a drop in oxygen saturation to 50% and bradycardia after a superdimension procedure.The patient was intubated and placed on a ventilator, and admitted to icu.The extended working channel was found to have an extra bend in the early portion of the procedure and subsequent tools were no longer able to be passed through it.The catheter was replaced and the procedure continued.The bleeding occurred after removal of the biopsy tools and when the physician went back to clean out the airways with just the bronchoscope at the end of the case.If additional information pertinent to the incident is obtained a follow-up report will be submitted.

• Brand Name: EDGE CATHETER SYSTEM
• Type of Device: GUIDE CATHETER
• Manufacturer (Section D): SUPERDIMENSION INC.; 161 cheshire lane; suite 100; minneapolis MN 55441
• Manufacturer Contact: sharon murphy ; 161 cheshire lane; suite 100; minneapolis, MN 55441 ; 2034925267
• MDR Report Key: 5347823
• MDR Text Key: 35181177
• Report Number: 3004962788-2015-00129
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102604
• 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: 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SD90EWCTE EDGE 90 EWC
• Device Lot Number: EK04357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SDCT01 - GENCUT BIOPSY TOOL, AKI00133-01 BIOPSY
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 71