MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE WIREGUIDED; DILATOR, ESOPHAGEAL

Model Number	M00558440
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: this event was reported by the sales representative.The healthcare facility is: (b)(6) medical center.(b)(6), phone number: (b)(6).Block h6: imdrf device code a041001 captures the reportable event of a balloon pinhole in the esophagus.
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used in the esophagus during an esophageal dilation procedure performed on (b)(6) 2023.During the procedure, the balloon was unable to inflate due to a leak.The customer reported the balloon had a hole.The procedure was completed with another cre wireguided dilatation balloon.There were no patient complications reported as a result of this event.

• Brand Name: CRE WIREGUIDED
• Common Device Name: DILATOR, ESOPHAGEAL
• 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: 18314405
• Report Number: 3005099803-2023-06547
• Device Sequence Number: 17671041
• Product Code: FDT
• UDI-Device Identifier: 08714729339373
• UDI-Public: 08714729339373
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/12/2023

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: 03/05/2026
• Device Model Number: M00558440
• Device Catalogue Number: 5844
• Device Lot Number: 0031374263
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2023
• 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 Sex: Unknown