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

Model Number	M00558490
Medical Device Problem Codes	Human-Device Interface Problem (2949); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a040609 captures the reportable event of balloon tip bent.
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used in the colon during a colonoscopy procedure performed on (b)(6) 2024.During the procedure, a photo of the device was provided by the customer and showed that the tip of the balloon catheter was bent.The procedure was completed with the original device.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used in the colon during a colonoscopy procedure performed on (b)(6) 2024.During the procedure, a photo of the device was provided by the customer and showed that the tip of the balloon catheter was bent.The procedure was completed with the original device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a040609 captures the reportable event of balloon tip bent.Block h10: investigation results the returned cre wireguided dilatation balloon was analyzed, and a visual and media inspection found that the tip of the guidewire was bent.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon tip bent was confirmed.The results of the analysis performed on the returned device found that the tip of the guidewire was bent.The tip bent found is likely to have occurred due to an excessive manipulation of the device without enough care during unpacking of the device.Therefore, the most probable root cause is an adverse event related to procedure.

• 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: 18818665
• Report Number: 3005099803-2024-00799
• Device Sequence Number: 8383294
• Product Code: FDT
• UDI-Device Identifier: 08714729339427
• UDI-Public: 08714729339427
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2024

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: 09/23/2025
• Device Model Number: M00558490
• Device Catalogue Number: 5849
• Device Lot Number: 0030404909
• 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: 02/09/2024
• Supplement Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2022
• 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 Sex: Male