MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MAXFORCE TTS; DILATOR, ESOPHAGEAL

Model Number	M00589180
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a maxforce tts dilatation balloon was used in a procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the balloon broke while inside the patient.There have been no patient complications reported as a result of this event.The patient 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: according to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a maxforce tts dilatation balloon was used in a procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the balloon broke while inside the patient.There have been no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be okay.It was reported that the device was used in the esophagus during an esophagogastroduodenoscopy (egd) with dilatation procedure.It was noted that the balloon suddenly deflated when dilated to 18.5mm while inside the patient.The procedure was completed with another 18-20mm balloon.

• Brand Name: MAXFORCE TTS
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8417546
• Report Number: 3005099803-2019-01202
• Device Sequence Number: 1612405
• Product Code: KNQ
• UDI-Device Identifier: 08714729099925
• UDI-Public: 08714729099925
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K934697
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2019

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: 08/17/2020
• Device Model Number: M00589180
• Device Catalogue Number: 8918
• Device Lot Number: 22532498
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2019
• Supplement Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 04/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 78