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

Model Number	M00530870
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a contour ercp cannula was intended to be used in a procedure.The exact procedure date was unknown.During preparation, it was pointed out before opening the package that a hair was noticed in between the outer packaging and the inner device pouch.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a1802 captures the reportable event of foreign material present in the packaging of the device.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a1802 captures the reportable event of foreign material present in the packaging of the device.Block h11: the returned contour ercp cannula was analyzed, and a visual evaluation was performed however, the outer bag of the product was not received, and the hair reported between the product package and outer bag could not be confirmed.Additionally, media inspection revealed an image shows a hair in the bag of the contour cannula.No other problems with the device were noted.Based on all gathered information, the outer bag was not returned for analysis and the reported contamination between the product package and outer bag could not be confirmed due to lack of evidence.Since the investigation findings do not lead to a clear conclusion about the cause of the reported events, the most probable cause of the event cannot be established.
Event or Problem Description
It was reported to boston scientific corporation that a contour ercp cannula was intended to be used in a procedure.The exact procedure date was unknown.During preparation, it was pointed out before opening the package that a hair was noticed in between the outer packaging and the inner device pouch.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.

• 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: 19198049
• Report Number: 3005099803-2024-01792
• Device Sequence Number: 12667603
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2024

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: 02/10/2026
• Device Model Number: M00530870
• Device Catalogue Number: 3087
• Device Lot Number: 0008803904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/03/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2024
• 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
• Patient Sex: Unknown