MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION APDL; CATHETER, BILIARY, DIAGNOSTIC

Model Number	33775
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was noted that the device tip broke off and was surgically retrieved.A 8w apdl catheter drainage was selected for use.During the procedure, it was noted that the device tip broke off and had to be surgically retrieved.No further patient complications were reported.
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2022 as no event date was reported.
Event or Problem Description
It was noted that the device tip broke off and was surgically retrieved.A 8w apdl catheter drainage was selected for use.During the procedure, it was noted that the device tip broke off and had to be surgically retrieved.No further patient complications were reported.
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2022 as no event date was reported.

• Brand Name: APDL
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13530072
• Report Number: 2134265-2022-00808
• Device Sequence Number: 14783677
• Product Code: FGE
• UDI-Device Identifier: 08714729115243
• UDI-Public: 08714729115243
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K924608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/12/2024
• Device Model Number: 33775
• Device Catalogue Number: 33775
• Device Lot Number: 0028196169
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 02/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown