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

Model Number	M00535700
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of radiopaque (ro) marker detached.
Event or Problem Description
It was reported to boston scientific corporation that a tandem xl was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, paint marker was not visible on the screen.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Additional information received on october 21, 2023: it was the radiopaque (ro) marker that was not visible on the screen, and the reason why it was not visible because it was detached.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of radiopaque (ro) marker detached.Block h10: the returned tandem xl was analyzed, and a visual evaluation noted that the working length was bent.The device was observed under magnification, the radiopaque (ro) marker was not visible in the device which is consistent with the findings per x-ray inspection.Destructive test was performed, and it was verified that the ro marker was missing.No other problems with the device were noted.The reported event of radiopaque (ro) marker detached was confirmed.Upon analysis, it was found that the device did not have the ro marker.Based on the condition of the device, the problem found was determined to be related with a manufacturing deficiency.It was also found that the working length was bent which was most likely caused by procedural factors and manipulation of the device.Based on all gathered information, the complaint will be documented as manufacturing deficiency.An investigation to address this problem has been initiated.
Event or Problem Description
It was reported to boston scientific corporation that a tandem xl was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, paint marker was not visible on the screen.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Additional information received on october 21, 2023: it was the radiopaque (ro) marker that was not visible on the screen, and the reason why it was not visible because it was detached.

• 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: 18140395
• Report Number: 3005099803-2023-06119
• Device Sequence Number: 8045579
• Product Code: ODD
• UDI-Device Identifier: 08714729146636
• UDI-Public: 08714729146636
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 12/26/2023

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: 07/05/2025
• Device Model Number: M00535700
• Device Catalogue Number: 3570
• Device Lot Number: 0031961131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2023
• Supplement Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 12/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2023
• 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