MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH CONTOUR ERCP CANNULA; ENDOSCOPE AND/OR ACCESSORIES

Model Number	M00530870
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual examination of the contour cannula revealed there was no damage to the device, but a foreign material (fiber) was found inside in the distal tip of the cannula.Functional inspection was performed.A guidewire was passed through the distal tip of the cannula without issue.A flow test was performed without issue; the foreign material (fiber) came off during the flow test.The jagwire guidewire used with this device was returned to bsc and had no damage; thus the foreign material was not from the guidewire.The complaint was not consistent with the reported event of tip damaged; however, foreign material (fiber) was found on the distal tip.Most likely, the defect was due to some operational or anatomical aspect of the procedure.Therefore, the most probable root cause for the complaint is operational context.A dhr (device history record) review was performed and no deviation was found.
Event or Problem Description
It was reported to boston scientific corporation that a contour ercp cannula was used in the distal bile duct during an expandable metallic stent (ems) procedure performed on (b)(6) 2017.According to the complainant, during procedure, a contour ercp cannula and a jagwire was inserted into the pancreatic duct.After placing the jagwire, the cannula was removed from the patient.When the cannula was reinserted to perform bile duct cannulation, it was noticed on the monitor that a fragment of the jagwire coating was inside the tip of the cannula.The cannula was removed from the patient and flushing was performed; the jagwire fragment came off.The bile duct cannulation was completed with this device and a non-bsc guidewire.Reportedly, there was no resistance encountered while moving the guidewire within the ercp cannula.However, a burr (rough area) was noted at the tip of the ercp cannula, and it was thought that this might have damaged the guidewire.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be "good".This event has been deemed a reportable event based on the investigation results; foreign material (fiber) was found inside the cannula tip.

• Brand Name: CONTOUR ERCP CANNULA
• Common Device Name: ENDOSCOPE AND/OR ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 6798635
• Report Number: 3005099803-2017-02535
• Device Sequence Number: 772439
• Product Code: KOG
• UDI-Device Identifier: 08714729099826
• UDI-Public: (01)08714729099826(17)20181126(10)G03106
• Combination Product (Y/N): N
• PMA/510(K) Number: K833417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/20/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/26/2018
• Device Model Number: M00530870
• Device Catalogue Number: 3087
• Device Lot Number: G03106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2017
• Initial Report FDA Received Date: 08/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1