MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Tandem XL; Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula

Model Number	M00535700
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a0501 captures the reportable event of radio opaque (ro) marker band detached.
Event or Problem Description
It was reported to boston scientific corporation that a tandem xl was used in the common bile duct and intrahepatic bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.During the procedure, the fluoroscopic marker at the tip was not visible under fluoroscopy.It was reported by the physician that the radio opaque (ro) marker may not have been present in the first place.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 25124975
• Report Number: 3005099803-2026-01690
• Device Sequence Number: 10694349
• Product Code: ODD
• UDI-Device Identifier: 08714729146636
• UDI-Public: (01)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
• 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): 07/30/2026

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 Model Number: M00535700
• Device Catalogue Number: M00535700
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/27/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2026
• Supplement Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 05/08/2026
• Supplement Report FDA Received Date: 07/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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