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

Model Number	M00558410
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
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 common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, after the balloon packaging was opened, the balloon could not be inflated, and it was found that the balloon was damaged.The specific damage was unknown.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 after the procedure was reported to be stable.
Additional Manufacturer Narrative
Block d2b: the remaining pro codes (product codes) are fdt and knq; reported here as pro codes (product codes) exceeded the character limit for the designated field.Block e1: initial reporter's facility name is (b)(6) reported here as the facility name exceeded the character limit for the designated field.Block h6: imdrf device code a04 captures the reportable event of a balloon damage.
Additional Manufacturer Narrative
D2b: the remaining pro codes (product codes) are fdt and knq; reported here as pro codes (product codes) exceeded the character limit for the designated field.E1: initial reporter's facility name is (b)(6) reported here as the facility name exceeded the character limit for the designated field.H6: imdrf device code a04 captures the reportable event of a balloon damage.H11: investigation results: the returned cre wireguided dilatation balloon was analyzed, and a visual evaluation found no damage.Functional/microscopic evaluation was performed, the balloon was inflated however it was not able to hold pressure due to a pinhole located approximately 26mm from the tip of the device.No other problems with the device were noted.With all the available information, boston scientific (bsc) concludes that the reported event of balloon damaged/defective was confirmed.The returned device was inflated however, it was not able to hold pressure due to a pinhole located approximately 26mm from the device tip.It is possible that the pinhole found on the balloon occurred due to procedural factors such as excess pressure, interaction with other devices, or anatomical conditions.Also, it is possible that interaction with a sharp surface during/previous to the procedure could have caused the failure found on the distal section of the balloon.Therefore, the most probable root cause is 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 common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, after the balloon packaging was opened, the balloon could not be inflated, and it was found that the balloon was damaged.The specific damage was unknown.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 after the procedure was reported to be stable.

• Brand Name: CRE WIREGUIDED
• Common Device Name: COLONOSCOPE 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21351559
• Report Number: 3005099803-2025-00345
• Device Sequence Number: 9003152
• Product Code: FDF
• UDI-Device Identifier: 08714729339342
• UDI-Public: (01)08714729339342(17)250403(10)29340712
• 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): 03/31/2025

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 Expiration Date: 04/03/2025
• Device Model Number: M00558410
• Device Catalogue Number: M00558410
• Device Lot Number: 0029340712
• 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: 01/15/2025
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2022
• 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: 52 YR
• Patient Sex: Male
• Patient Weight: 68 KG