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

Model Number M00554500

Device Problem Break (1069)

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

Event Date 12/30/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a rigiflex ii dilatation balloon was used in the esophagus during an esophageal dilation procedure performed on (b)(6) 2022.During the procedure for test period, the staff opened the packaged and noticed that the catheter was broken.The procedure was completed with another cre fixed wire dilatation balloon device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

(b)(4).

• 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): CREGANNA MEDICAL S R L; metro free trade zone; building 3 c; heredia ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16243705
• MDR Text Key: 308553138
• Report Number: 3005099803-2023-00199
• Device Sequence Number: 1
• Product Code: PID
• UDI-Device Identifier: 08714729719106
• UDI-Public: 08714729719106
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050232
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2023
• Device Model Number: M00554500
• Device Catalogue Number: 5450
• Device Lot Number: C311372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2022
• 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