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

Model Number	M00530870
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf impact code f12 is being used to capture the reportable event of unspecified patient injury.
Event or Problem Description
It was reported to boston scientific corporation that a contour ercp cannula was attempted to be used during a procedure performed on (b)(6) 2024.During the procedure, the guidewire was unable to cross with this device.Another guidewire was used with this device, but the guidewire could not cross as well.The procedure was completed with another device.The patient was reported to have an injury.No further information has been obtained despite good-faith efforts.
Event or Problem Description
It was reported to boston scientific corporation that a contour ercp cannula was attempted to be used during a procedure performed on (b)(6) 2024.During the procedure, the guidewire was unable to cross with this device.Another guidewire was used with this device, but the guidewire could not cross as well.The procedure was completed with another device.The patient was reported to have an injury.No further information has been obtained despite good-faith efforts.
Additional Manufacturer Narrative
Block h6: imdrf impact code f12 is being used to capture the reportable event of unspecified patient injury.Block h11: investigation results the returned contour ercp cannula was analyzed, and a visual inspection found no damages to the device.Functional inspection was performed and a mandrel of 0.018 was inserted in the cannula to see if there was any obstruction or internal diameter below specification in the device.Mandrel passed freely inside the cannula and came out form the tip without problems.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of an unspecified patient injury was unable to be confirmed.The patient was reported to have an injury, but the details of this injury and additional information were not reported despite good faith efforts.Additionally, a labeling review performed confirmed these events are anticipated within labeling documents therefore known inherent risk of device is selected for these events.The limited information provided is not enough to confirm a device misusage by the customer.Additional efforts to gather more information were unsuccessful.Since the investigation was unable to identify any damage or malfunction related to the reported allegation, therefore, the most probable root cause is no problem detected.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a contour ercp cannula was attempted to be used during a procedure performed on (b)(6) 2024.During the procedure, the guidewire was unable to cross with this device.Another guidewire was used with this device, but the guidewire could not cross as well.The procedure was completed with another device.The patient was reported to have an injury.No further information has been obtained despite good-faith efforts.Additional information received on december 16, 2024: it was reported that there was no harm to the patient's health.
Additional Manufacturer Narrative
B1 (adverse event/product problem): there was no adverse event.B2 (outcomes attrib to adv event): no outcomes attributable to event.B5 (describe event or problem) and block h6 (patient codes and impact codes) have been updated.H2 (additional information): it was reported that the guidewire was unable to cross with this device and the patient was reported to have an injury.Additional information was received from the customer on december 16, 2024, that there was no harm to the patient's health.Additionally, if there is difficulty advancing a guidewire through the anatomy or another device, the guidewire can be exchanged.This is unlikely to cause or contribute to a death or serious injury if the malfunction were to recur.As there is no reportable allegation against the device itself and there was no serious injury, boston scientific no longer considers this to be a reportable event.

• 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: 19538018
• Report Number: 3005099803-2024-02814
• Device Sequence Number: 12368421
• Product Code: ODD
• UDI-Device Identifier: 08714729099826
• UDI-Public: 08714729099826
• 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,Followup,Followup
• Report Date (Section B): 01/09/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/06/2026
• Device Model Number: M00530870
• Device Catalogue Number: 3087
• Device Lot Number: 0008884654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 07/15/2024; 12/16/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 08/07/2024; 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown