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

Model Number	M00558340
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	04/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2019 as no event date was reported.(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 cre fixed wire dilatation balloon was used during an esophagogastroduodenoscopy (egd) procedure on an unknown date.According to the complainant, during the procedure, it was noted that the balloon ruptured inside the patient which caused minimal tissue damage.Reportedly, the injury was treated "normally" and the patient was monitored for bleeding.The patient condition at the conclusion of the procedure was reported to be fine.
Event or Problem Description
It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used during an esophagogastroduodenoscopy (egd) procedure on an unknown date.According to the complainant, during the procedure, it was noted that the balloon ruptured inside the patient which caused minimal tissue damage.Reportedly, the injury was treated "normally" and the patient was monitored for bleeding.The patient condition at the conclusion of the procedure was reported to be fine.
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2019 as no event date was reported.Problem code 1074 captures the reportable event of balloon burst.Investigation results: a visual examination of the returned complaint device found that the balloon was torn longitudinally.No other issue was noted on the device.Functional evaluation could not be performed due to the condition of the returned device.This failure is likely due to the manner as the device was handled and manipulated.A labeling review was performed and from the information available, this device was not used per the directions for use (dfu)/product label as the device was not used in the indicated anatomy location of the esophagus.It is most likely that the failure may be related to the device being used in an anatomy location for which it is not recommended to be used, and this condition could have caused the damage found in the balloon, affecting the performance and intended purpose of the device and leading to the cause of the reported adverse event.Therefore, the most probable root cause is failure to follow instructions.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

• Brand Name: CRE FIXED WIRE
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8566692
• Report Number: 3005099803-2019-02129
• Device Sequence Number: 11520510
• Product Code: KNQ
• UDI-Device Identifier: 08714729201991
• UDI-Public: 08714729201991
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K971320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/26/2020
• Device Model Number: M00558340
• Device Catalogue Number: 5834
• Device Lot Number: 0022047413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 06/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention