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

Model Number	M00535700
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a180104 captures the reportable event of presence of foreign material in the guidewire lumen.
Event or Problem Description
It was reported to boston scientific corporation that a tandem xl was intended to be used in a procedure performed on (b)(6) 2023.During preparation outside the patient, when the device was removed from the packaging, a foreign object was found in the guidewire lumen of the device.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: a photo of the complaint device outside the patient was provided by the customer and showed a foreign material in the guidewire lumen.
Event or Problem Description
It was reported to boston scientific corporation that a tandem xl was intended to be used in a procedure performed on (b)(6) 2023.During preparation outside the patient, when the device was removed from the packaging, a foreign object was found in the guidewire lumen of the device.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: a photo of the complaint device outside the patient was provided by the customer and showed a foreign material in the guidewire lumen.
Additional Manufacturer Narrative
Block h6: imdrf device code a180104 captures the reportable event of presence of foreign material in the guidewire lumen.Block h10: the returned tandem xl was analyzed, and there was no foreign material found inside the guidewire lumen or any other side of the device, which was consistent with the findings when the device was observed under magnification; however, per media analysis on provided photo, it showed a foreign material as reported.No problems with the device were noted.The reported event of foreign material inside the guidewire lumen cannot be confirmed.Upon analysis, there was no foreign material found inside the guidewire lumen or any other side of the device.There might have been some environmental situations in the workspace when the procedure was being performed that could have caused the foreign object to get near the device once this was opened from its package; therefore, the most probable root cause of this complaint is cause not established.

• Brand Name: TANDEM XL
• Common Device Name: ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CANNULA
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17724689
• Report Number: 3005099803-2023-04762
• Device Sequence Number: 7213194
• Product Code: ODD
• UDI-Device Identifier: 08714729146636
• UDI-Public: 08714729146636
• 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
• Report Date (Section B): 11/13/2023

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: 05/02/2025
• Device Model Number: M00535700
• Device Catalogue Number: 3570
• Device Lot Number: 0031545957
• 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: 08/21/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2023
• 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