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 Consequences Or Impact To Patient (2199)
Date of Event	10/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a rigiflex ii dilatation balloon was used in the lower esophagus and cardia during a dilation procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the balloon suddenly burst when attempted to be inflated.The procedure was not completed as the same device was unavailable.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be okay.
Event or Problem Description
It was reported to boston scientific corporation that a rigiflex ii dilatation balloon was used in the lower esophagus and cardia during a dilation procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the balloon suddenly burst when attempted to be inflated.The procedure was not completed as the same device was unavailable.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be okay.
Additional Manufacturer Narrative
Block h6: problem code 1074 captures the reportable issue of balloon burst.Block h10: investigation result a visual examination of the returned complaint device found that the product was received inside a plastic pouch which contained yellow contamination spots; therefore the device was not opened nor was the balloon removed from the bag.The device was manipulated from the outside, and it was observed that the balloon had an opening from the distal end to the proximal end of the balloon material which confirmed the reported event of balloon burst.This failure is likely due to factors or conditions related to procedure during the use of the device, such as the manner in which the device was handled and manipulated, that could have affected its performance and its intended purpose.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/product label.

• Brand Name: RIGIFLEX II
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9440340
• Report Number: 3005099803-2019-05834
• Device Sequence Number: 3603821
• Product Code: PID
• UDI-Device Identifier: 08714729719106
• UDI-Public: 08714729719106
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K050232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2020

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: 08/29/2020
• Device Model Number: M00554500
• Device Catalogue Number: 5450
• Device Lot Number: C019862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 02/22/2020
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1