MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE PRO; BALLOON DILATOR

Model Number	M00558660
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Adverse event probem imdrf device code a150208 captures the reportable event of device being stuck in scope and used in another procedure.Imdrf impact code f1007 is being used to capture the reportable event of exposure to contaminated device/risk of infection.
Event or Problem Description
It was reported to boston scientific corporation that the physician performed a colonoscopy procedure on (b)(6) 2023.During the procedure, the physician inserted biopsy forceps into the biopsy port of the scope and pushed a clear plastic sheath into the colon of the patient.The plastic sheath was removed from the patient using a snare and the procedure was completed at this time.The clear sheath appeared to be a sheath from a cre pro wireguided dilatation balloon used during the previous procedure that was stuck in the scope.The physician reported that no immediate harm was caused to the patient but noted a risk of infection related to the improperly reprocessed scope.There were no patient complications reported as a result of this event.

• Brand Name: CRE PRO
• Common Device Name: BALLOON DILATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16583753
• Report Number: 3005099803-2023-01334
• Device Sequence Number: 4681518
• Product Code: FGE
• UDI-Device Identifier: 08714729797548
• UDI-Public: 08714729797548
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K112994
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/21/2023

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: 10/31/2024
• Device Model Number: M00558660
• Device Catalogue Number: 5866
• Device Lot Number: 0028475447
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• 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