MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CONTOUR ERCP CANNULA; ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CANNULA

Model Number	M00530880
Medical Device Problem Codes	Difficult to Advance (2920); Device Contamination with Chemical or Other Material (2944); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(initial reporter city, state): aizuwakamats, fukushima prefecture block h6: medical device problem code a180104 captures the reportable investigation results of foreign material present at the tip.Block h10: the returned contour ercp cannula was analyzed, and a visual evaluation noted that the device had white and black residue in the catheter.Additionally, there was a bend in the working length near the green label.A functional test was performed with two guidewires, navipro and novagold, and they passed through the distal tip with no problems.The unit was reviewed with the go pin gauge and it did not present any difficulty in the insertion.No other problems with the device were noted.The product analysis revealed there was an unknown white and black residue in the device.The residues could be from body fluids or a residue of the plastic material in the tip of the device; however, the exact nature of the residues is unknown.The reported problem of difficulty advancing the guidewire was not confirmed; however, during analysis it was found that the device was bent which could have contributed to the reported problem.It is likely that this could have been generated due to procedural factors such as handling technique or the force applied combined with resistance experienced during the procedure.Based on all available information, the conclusion code of the reported event is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a contour ercp cannula was used in the common bile duct during a procedure performed on (b)(6), 2022.During the procedure, this contour ercp cannula was used with a non bsc guidewire during cannulation.When the contour ercp cannula was attempted to be pulled out leaving the guidewire in place, it was observed that there was difficulty removing the device; hence, the replacement of the device could not be performed.The procedure was completed another of the same device.It was reported that the guidewire was advanced without any problem.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation results: the product analysis revealed there was an unknown white and black residue in the device.Please refer to block h10 for full investigation details.

• Brand Name: CONTOUR ERCP CANNULA
• Common Device Name: ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CANNULA
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): LAKE REGION MEDICAL; 31c butterfield trail; el paso TX 79906
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15152915
• Report Number: 3005099803-2022-04231
• Device Sequence Number: 5601297
• Product Code: ODD
• UDI-Device Identifier: 08714729099833
• UDI-Public: 08714729099833
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K833417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/02/2022

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: 07/09/2023
• Device Model Number: M00530880
• Device Catalogue Number: 3088
• Device Lot Number: 0006435347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown