MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RIGIFLEX II; DILATOR, ESOPHAGEAL

Model Number M00554500

Device Problem Burst Container or Vessel (1074)

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

Event Date 07/06/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a0402 captures the reportable event of balloon burst.

Event Description

It was reported to boston scientific corporation that a rigiflex ii balloon was used in the lower esophageal sphincter (les) during a dilatation procedure performed on (b)(6) 2023.During the procedure, the balloon burst.The customer stated that no pieces of the balloon detached inside the patient.The procedure was completed with the original device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be okay.

• Brand Name: RIGIFLEX II
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; metro free trade zone; building 3 c; heredia ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17393704
• MDR Text Key: 319795777
• Report Number: 3005099803-2023-04014
• Device Sequence Number: 1
• Product Code: PID
• UDI-Device Identifier: 08714729719106
• UDI-Public: 08714729719106
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K050232
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2023
• Device Model Number: M00554500
• Device Catalogue Number: 5450
• Device Lot Number: C304517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2022
• 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