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

Model Number	M00558640
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable event of balloon torn material.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the esophagus during an esophagus dialation procedure to treat jaundice performed on (b)(6) 2025.Post-procedure, the cre balloon developed a tear, which failed to inflate.The procedure was completed with the original device.No further information has been obtained despite good-faith efforts.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h2 (correction): block e1 (initial reporter, initial reporter address and zip/post code) have been corrected.Block h6: imdrf device code a0414 captures the reportable event of balloon torn material.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the esophagus during an esophagus dilation procedure to treat jaundice performed on (b)(6) 2025.Post-procedure, the cre balloon developed a tear, which failed to inflate.The procedure was completed with the original device.No further information has been obtained despite good-faith efforts.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h2 (correction): block e1 (initial reporter, initial reporter address and zip/post code) have been corrected.Block h6: imdrf device code a0414 captures the reportable event of balloon torn material.Block h11: investigation results: the returned cre pro wireguided dilatation balloon was analyzed and a visual/microscopic evaluation found it was longitudinally torn.No other problems with the device were noted.With all the available information, boston scientific (bsc) concludes the reported event of balloon torn material was confirmed.The returned device revealed the balloon was longitudinally torn.The longitudinal tear found in the balloon is likely to have occurred due to factors encountered during the procedure, it can be due to excess pressure.These factors and interactions could influence the damage found in the balloon.Also, it is possible that interaction with a 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 pro wireguided dilatation balloon was used in the esophagus during an esophagus dialation procedure to treat jaundice performed on (b)(6) 2025.Post-procedure, the cre balloon developed a tear, which failed to inflate.The procedure was completed with the original device.No further information has been obtained despite good-faith efforts.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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22324076
• Report Number: 3005099803-2025-02920
• Device Sequence Number: 8819154
• Product Code: FGE
• UDI-Device Identifier: 08714729797524
• UDI-Public: (01)08714729797524(17)271107(10)35236366
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: TW
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/13/2025

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: M00558640
• Device Lot Number: 0035236366
• 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: 06/04/2025
• Supplement Date Received by Manufacturer: 06/23/2025; 07/23/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 07/16/2025; 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2024
• 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 Sex: Unknown