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

Model Number	M00554500
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a rigiflex ii dilatation balloon was used in the lower esophageal sphincter during an endoscopic dilation procedure performed on (b)(6) 2022.During the procedure, the balloon ruptured at 20 psi after only one minute of dilating.The customer stated that no pieces of the balloon detached inside the patient.The procedure had already been completed successfully with the original device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Block h6: device code a0402 captures the reportable event of balloon burst.Block h10: investigation results: the returned rigiflex ii dilatation balloon was analyzed and a visual examination found that the balloon burst.The he tyvek/mylar pouch is missing.With all the available information, boston scientific concludes the reported event of balloon burst was confirmed.It is unlikely a manufacturing issue since controls are in place to detect this failure mode at the manufacturing process, additionally there is no evidence that the device was not used in accordance with the ifu.Therefore, the most probable root cause is cause traced to component failure.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a rigiflex ii dilatation balloon was used in the lower esophageal sphincter during an endoscopic dilation procedure performed on (b)(6) 2022.During the procedure, the balloon ruptured at 20 psi after only one minute of dilating.The customer stated that no pieces of the balloon detached inside the patient.The procedure had already been completed successfully with the original device.There were no patient complications reported as a result of this event.

• Brand Name: RIGIFLEX II
• Common Device Name: 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: 15998007
• Report Number: 3005099803-2022-07421
• Device Sequence Number: 17784536
• Product Code: PID
• UDI-Device Identifier: 08714729719106
• UDI-Public: 08714729719106
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K050232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2023

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: 05/05/2023
• Device Model Number: M00554500
• Device Catalogue Number: 5450
• Device Lot Number: C304517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2022
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2022
• 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 Age: 69 YR
• Patient Sex: Female