MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RX ERCP CANNULA; CATHETER, CHOLANGIOGRAPHY

Model Number	M00545770
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	11/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Approximated based on the date the manufacturer became aware of the event.(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that an rx ercp cannula was intended to be used in a procedure.The exact procedure date was unknown.Upon checking the device outside the patient, a hair was found inside the packaging.It was reported that the device was not unpacked and there was no damage noticed on the device pouch or seal.The procedure was completed with another of the same device.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 (device codes): imdrf device code a1802 captures the reportable event of foreign material present in the packaging of the device.Block h10: the returned rx ercp cannula was analyzed, and a visual evaluation noted that it was inside its original pouch, and when it was opened there was no foreign material found inside the packaging.Per media analysis on the provided photo, it was observed that a foreign material was present in the packaging.No problems with the device were noted.The reported event of foreign material inside the packaging was not confirmed.Upon analysis, when the packaging of the device was opened, there was no foreign material present inside the packaging.It is possible that the foreign material was in additional packaging, which does not compromise the integrity of the device.Based on all gathered information, the overall conclusion for the complaint will be "no problem detected" since the device complaint or problem cannot be confirmed.Block h2 (additional information): block b5 has been updated based on the additional information received on february 20, 2023.
Event or Problem Description
It was reported to boston scientific corporation that an rx ercp cannula was intended to be used in a procedure.The exact procedure date was unknown.Upon checking the device outside the patient, a hair was found inside the packaging.It was reported that the device was not unpacked and there was no damage noticed on the device pouch or seal.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.Additional information received on february 20, 2023: note: one of the photos provided by the customer shows the complaint device inside its original packaging with a foreign material inside the package.

• Brand Name: RX ERCP CANNULA
• Common Device Name: CATHETER, CHOLANGIOGRAPHY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15993603
• Report Number: 3005099803-2022-07569
• Device Sequence Number: 12314138
• Product Code: GBZ
• UDI-Device Identifier: 08714729268659
• UDI-Public: 08714729268659
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K970054
• 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): 03/08/2023

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: 02/10/2024
• Device Model Number: M00545770
• Device Catalogue Number: 4577
• Device Lot Number: 0028845394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2022
• Supplement Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2022
• 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