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

Model Number M00558370

Device Problems Deflation Problem (1149); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 Description

It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the balloon could not be fully deflated and got stuck in the scope.It was also noted that the balloon material bunched up.Another scope and cre fixed wire dilatation balloon were used to complete the procedure.There have been no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: problem code 1149 captures the reportable event of balloon failed to deflate.Block h10: investigation results a visual examination of the returned complaint device found that the catheter was twisted.Additionally, it was noted that the catheter was mechanically cut near the balloon.The balloon portion of the device was not returned.Dimensional examination of the catheter was performed and was measured in three sections; distal, medium and proximal.The three sections were within specification.Functional analysis was unable to be performed due to the condition of the device.Based on the available information, it is possible that factors encountered during the procedure, the technique used by the physician during the procedure, and/or the interaction between the scope and the balloon could have caused the balloon damage.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.

Event Description

It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the balloon could not be fully deflated and got stuck in the scope.It was also noted that the balloon material bunched up.Another scope and cre fixed wire dilatation balloon were used to complete the procedure.There have been no patient complications reported as a result of this event.

• Brand Name: CRE FIXED WIRE
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9491811
• MDR Text Key: 189841430
• Report Number: 3005099803-2019-06040
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 08714729195993
• UDI-Public: 08714729195993
• Combination Product (y/n): N
• PMA/PMN Number: K971320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2021
• Device Model Number: M00558370
• Device Catalogue Number: 5837
• Device Lot Number: 0024512124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Date Manufacturer Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1