MAUDE Adverse Event Report: HERAEUS MEDICAL COMPONENTS, LLC NOVAGOLD; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number 5201

Device Problem Fracture (1260)

Patient Problems Fever (1858); Foreign Body In Patient (2687)

Event Date 04/24/2018

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned, therefore no device evaluation could be performed.During records review ncmrs were identified but based on the actions and disposition, those issues would not have resulted in the event identified in this complaint.Heraeus is unable to comment on the condition of the device or the cause of the occurence.If additional relevant information is received, a follow up report will be submitted.

Event Description

It was reported that ercp was performed for removal of stone.Since cannulation was difficult, contour 5-4-3 tip and nova gold were used.The physician attempted to perform cannulation aiming at the bile duct.It could only be inserted into the pancreatic duct, so in order to perform pancreatic ductal gw method, the inserted nova gold was placed in the pancreatic duct and when the physician tried to remove the cannula, the tip of the nova gold got detached.According to the assistant, there was a feeling of resistance when removing the cannula.The tip of nova gold remained in the pancreatic duct, so accident report will be reported at the facility.Deliberate investigation has been requested about the occurrence of the issue.

Manufacturer Narrative

Follow up # 1 narratives.Customer returned the sample for physical analysis.The tip of the guidewire was missing and the core was bent.The coil unwrapped from the core to the glued joint.During records review of the lot number provided, there were no identified non-conformities that would have directly contributed to the failure mode observed.There were ncmrs identified but based on the descriptions of each ncmr, actions and disposition, those issues would not have resulted in the event identified in this complaint.Heraeus is unable to comment on the condition of the device or the cause of the occurrence.However, it is likely that tension and perhaps fatigue combined contributed to this failure.If additional relevant information is received, a follow up report will be submitted.This submission does not constitute a determination or admission that a device has malfunction has occured or that the device is related to a death or serious injury.

• Brand Name: NOVAGOLD
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): HERAEUS MEDICAL COMPONENTS, LLC; 2605 fernbrook lane n; suite j; plymouth MN 55447
• MDR Report Key: 7560847
• MDR Text Key: 109900374
• Report Number: 2135342-2018-00004
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 08714729892045
• UDI-Public: (01)08714729892045(17)201015(10)PL01486
• Combination Product (y/n): N
• PMA/PMN Number: K150225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/15/2020
• Device Model Number: 5201
• Device Catalogue Number: 5201
• Device Lot Number: PL01486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/10/2018
• Initial Date FDA Received: 06/01/2018
• Supplement Dates Manufacturer Received: 05/10/2018
• Supplement Dates FDA Received: 06/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 95 YR
• Patient Weight: 41