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

Model Number M00558380

Device Problems Difficult to Advance (2920); Material Integrity Problem (2978)

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

Event Date 03/27/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used in esophagus during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6), 2023.During preparation, before inserting the balloon into the scope something was noted to be off with the balloon, it was very hard to push down the scope channel.It was also noticed that the balloon was flat and defective, and the balloon looks different.The procedure was completed with another cre fixed wire dilatation balloon.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Imdrf code a04 captures the reportable event of balloon damaged.

• Brand Name: CRE FIXED WIRE
• 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 ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16773871
• MDR Text Key: 313779964
• Report Number: 3005099803-2023-02002
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 08714729202011
• UDI-Public: 08714729202011
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00558380
• Device Catalogue Number: 5838
• Device Lot Number: 0030490288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2022
• 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