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

Model Number M00558790

Device Problems Leak/Splash (1354); Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/13/2024

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a cre pro gi wireguided dilatation balloon was being prepared for use in a procedure to be performed on (b)(6) 2024.During preparation, outside of the patient before insertion, the balloon was inflated however, the balloon was leaking water.The balloon was not used in the procedure.The type of procedure and anatomy location of the planned procedure are unknown and is being reported as the leak could have potentially occurred in the esophagus.The procedure was completed with another cre pro gi wireguided dilatation balloon.There were no patient complications reported as a result of this event.Note: the instructions for use (ifu) indicate that this balloon should not be pre-inflated prior to use in the procedure.However, the customer reported that the balloon was pre-inflated outside of the patient.

Manufacturer Narrative

Block h6: imdrf device code a0504 captures the reportable event of balloon leak with an unknown procedure type and anatomy location.

• Brand Name: CRE PRO GI
• Type of Device: 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: 18861631
• MDR Text Key: 337680315
• Report Number: 3005099803-2024-00889
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K971320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00558790
• Device Catalogue Number: 5879
• Device Lot Number: 0032495700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1