MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE WIREGUIDED; DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	M00558400
Medical Device Problem Codes	Leak/Splash (1354); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was being prepared for use in the esophagus during an esophageal stenosis dilatation procedure to be performed on (b)(6), 2023.During preparation, an inflation examination was performed outside the patient's body and found the balloon was leaking liquid.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: the instructions for use (ifu) indicate that this balloon should not be pre-inflated prior to use in the procedure.However, the customer reported that the balloon was pre-inflated outside of the patient.
Additional Manufacturer Narrative
Block e1: the initial reporter facility name is: (b)(6).Block h6: imdrf device code a0504 captures the reportable event of balloon leak in the esophagus.
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was being prepared for use in the esophagus during an esophageal stenosis dilatation procedure to be performed on (b)(6) 2023.During preparation, an inflation examination was performed outside the patient's body and found the balloon was leaking liquid.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: the instructions for use (ifu) indicate that this balloon should not be pre-inflated prior to use in the procedure.However, the customer reported that the balloon was pre-inflated outside of the patient.
Additional Manufacturer Narrative
Block e1: the initial reporter facility name is: affiliated hospital of inner mongolia chifeng college block h6: imdrf device code a0504 captures the reportable event of balloon leak in the esophagus.Block h10: investigation results the returned cre wireguided dilatation balloon was analyzed, and a visual examination found that the balloon had a longitudinal tear.No damages were found in the catheter of the device.Functional analysis was performed, and the balloon was not able to be inflated due to the longitudinal tear found in the balloon.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of a balloon leak was confirmed.The results of the analysis performed on the returned device showed that the balloon had a longitudinal tear.It is possible that during the procedure the device has interacted with some sharp surface or other devices that may have caused the longitudinal tear of the balloon.Perhaps the manipulation, technique used, or patient's anatomical conditions could have also contributed to this event.Therefore, the most probable root cause is an adverse event related to procedure.A labeling review was performed, and from the information available, this device was not used per the instructions for use (ifu)/product label.

• Brand Name: CRE WIREGUIDED
• Common Device Name: DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17692153
• Report Number: 3005099803-2023-04687
• Device Sequence Number: 6057447
• Product Code: FDT
• UDI-Device Identifier: 08714729339335
• UDI-Public: 08714729339335
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K110833
• 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): 12/04/2023

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: 03/30/2025
• Device Model Number: M00558400
• Device Catalogue Number: 5840
• Device Lot Number: 0029316980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/14/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2022
• 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 Age: 60 YR
• Patient Sex: Male
• Patient Weight: 75 KG