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

Model Number	M00558630
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	12/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: the initial reporter facility name: (b)(6).Block h6: imdrf device code a0504 captures the reportable event of a balloon leak in the esophagus.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was being prepared for use in the esophagus during a dilatation of esophagus procedure to be performed on (b)(6) 2023.During preparation, the nurse unpacked the balloon and pre-injected liquid for examination.The balloon was found to leak liquid at the junction between the front end of the balloon and the catheter, and the balloon could not be fully inflated.The procedure was completed with another cre pro wireguided dilatation balloon.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: (b)(6).Block h6: imdrf device code a0504 captures the reportable event of a balloon leak in the esophagus.Block h10: investigation results: the returned cre pro dilatation balloon was analyzed, and a visual examination found that the balloon and catheter of the device had no damages.Functional analysis was performed, and the balloon was inflated without a problem.However, the balloon would not hold pressure due to a pinhole in the balloon (distal section), located approximately 12 mm from the tip.Microscopic inspection found a pinhole located approximately at 12 mm from the tip of the device.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon leak was confirmed.The results of the analysis performed on the returned device found that the balloon had a pinhole located approximately at 12 mm from the tip of the device.The pinhole found is likely to have occurred due to procedural factors such as excess of pressure or interaction with other devices.Also, it is possible that interaction with a sharp surface during or previous the procedure, could have caused the problem found on the distal section of the balloon.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.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was being prepared for use in the esophagus during a dilatation of esophagus procedure to be performed on (b)(6) 2023.During preparation, the nurse unpacked the balloon and pre-injected liquid for examination.The balloon was found to leak liquid at the junction between the front end of the balloon and the catheter, and the balloon could not be fully inflated.The procedure was completed with another cre pro wireguided dilatation balloon.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.

• Brand Name: CRE PRO
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• 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: 18387291
• Report Number: 3005099803-2023-06853
• Device Sequence Number: 2759635
• Product Code: FGE
• UDI-Device Identifier: 08714729797517
• UDI-Public: 08714729797517
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2024

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: 01/03/2026
• Device Model Number: M00558630
• Device Catalogue Number: 5863
• Device Lot Number: 0030986664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2023
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 02/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2023
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 77 KG