MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ZERO TIP; BRONCHOSCOPE ACCESSORY

Model Number	M00513210
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Basket wire kinked after placement into common bile duct, getting stuck.

• Brand Name: ZERO TIP
• Common Device Name: BRONCHOSCOPE ACCESSORY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 16101849
• Report Number: 16101849
• Device Sequence Number: 6186443
• Product Code: KTI
• UDI-Device Identifier: 08714729415008
• UDI-Public: (01)08714729415008(17)1016(10)
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/22/2022
• Report Date (Section F): 12/22/2022

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: M00513210
• Device Catalogue Number: M00513210
• Device Lot Number: 30356638
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/05/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/05/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 103 KG
• Patient Race: White
• Date Report Sent to FDA: 12/22/2022