MAUDE Adverse Event Report: HERAEUS MEDICAL COMPONENTS NOVAGOLD GUIDEWIRE; ENDOSCOPIC GUIDEWIRE

Model Number M00552011

Device Problems Material Separation (1562); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/09/2021

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

Endoscopic retrograde cholangiopancreatography (ercp) wire got stuck and broke inside of the patient during and ercp.The wire was retrieved and nothing remained in the patient.Per salesforce event (b)(4), it was reported that: novagold was experiencing a lot of resistance at the tip of the cannula and when the nurse pulled the wire back it had stripped the gold tip off into the cannula tip and away from the wire core.What troubleshooting steps took place? tried to push wire through the tip of the cannula and it didn't pass through what is the next course of action? nothing resolved it, when they pulled the wire out it stripped the gold tip off.Failure modes related to this device include: device-guidewire interaction were the issues present upon opening the package?: no indicate any attached/related device(s): novagold guidewire device 2 of 2 event date: (b)(6) 2021.

Manufacturer Narrative

Date of this report: 12-aug-2021.

• Brand Name: NOVAGOLD GUIDEWIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE
• Manufacturer (Section D): HERAEUS MEDICAL COMPONENTS; 5030 centerville road; st. paul MN 55127
• Manufacturer (Section G): HERAEUS MEDICAL COMPONENTS, SRL; parque industrial zona franca; la lima guadalupe building 29; cartago, costa rica 30106 ; CS 30106
• Manufacturer Contact: tim desaulniers ; 5030 centerville road; st. paul, MN 55127 ; 6123252003
• MDR Report Key: 12743405
• MDR Text Key: 282113011
• Report Number: 3008988055-2021-00003
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 08714729892045
• UDI-Public: (01)08714729892045(17)240322(10)9007400660
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150225
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 08/12/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2024
• Device Model Number: M00552011
• Device Catalogue Number: M00552011
• Device Lot Number: 9007400660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/16/2021
• Initial Date FDA Received: 11/03/2021
• Supplement Dates Manufacturer Received: 08/16/2021
• Supplement Dates FDA Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other