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

Model Number	M00558640
Medical Device Problem Codes	Burst Container or Vessel (1074); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was attempted to be used in the bile duct during a bile duct stenosis procedure performed on (b)(6) 2024.During the procedure, the balloon burst.It was reported that no piece of the balloon detached inside the patient.The procedure was completed with another cre 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.
Additional Manufacturer Narrative
Block a4: the patient's weight is 74.5 kg; reported here as the patient's weight exceeded the character limit for the designated field.Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.
Additional Manufacturer Narrative
Block a4: the patient's weight is 74.5 kg; reported here as the patient's weight exceeded the character limit for the designated field.Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.Block h11: investigation results the returned cre pro wireguided dilatation balloon was analyzed, and a visual/microscopic inspection found a longitudinal tear.No other problems with the device were noted.With all the available information, boston scientific (bsc) concludes the reported event of balloon burst was not confirmed.The longitudinal tear found in the balloon could have been interpreted by the customer as the reported event of a balloon burst.This problem is likely to have occurred due to factors encountered during the procedure, it can be due to excess pressure, interaction with other devices, or anatomical factors.These factors and interactions could influence the damage found in the balloon.It is possible that interaction with any kind of sharp surface during or previous to the procedure could create friction on the balloon causing the longitudinal tear.Therefore, the most probable root cause is an adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was attempted to be used in the bile duct during a bile duct stenosis procedure performed on (b)(6) 2024.During the procedure, the balloon burst.It was reported that no piece of the balloon detached inside the patient.The procedure was completed with another cre 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.
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was attempted to be used in the bile duct during a bile duct stenosis procedure performed on (b)(6) 2024.During the procedure, the balloon burst.It was reported that no piece of the balloon detached inside the patient.The procedure was completed with another cre 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.
Additional Manufacturer Narrative
Block a4: the patient's weight is 74.5 kg; reported here as the patient's weight exceeded the character limit for the designated field.Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.Block h11 (investigation results) have been updated.Block h11: investigation results: the returned cre pro wireguided dilatation balloon was analyzed, and a visual/microscopic inspection found a longitudinal tear.No other problems with the device were noted.With all the available information, boston scientific (bsc) concludes the reported event of balloon burst was not confirmed.The longitudinal tear found in the balloon could have been interpreted by the customer as the reported event of a balloon burst.This problem is likely to have occurred due to factors encountered during the procedure, it can be due to excess pressure, interaction with other devices, or anatomical factors.These factors and interactions could influence the damage found in the balloon.It is possible that interaction with any kind of sharp surface during or previous to the procedure could create friction on the balloon causing the longitudinal tear.Therefore, the most probable root cause is no problem detected.

• 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20355826
• Report Number: 3005099803-2024-04842
• Device Sequence Number: 8086778
• Product Code: FGE
• UDI-Device Identifier: 08714729797524
• UDI-Public: 08714729797524
• 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,Followup
• Report Date (Section B): 11/21/2024

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 Model Number: M00558640
• Device Catalogue Number: 5864
• Device Lot Number: 0033320565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 10/31/2024; 11/21/2024
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 11/20/2024; 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2024
• 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: 43 YR
• Patient Sex: Male