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

Model Number M00558370

Device Problems Break (1069); Material Deformation (2976); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).Visual examination of the returned complaint device revealed the catheter was broken in two different sections and both sections were returned.The shaft was found twisted next to the balloon hub.Also, the balloon was found torn circumferentially next to the distal bond.Additionally, the device showed signs indicating it was highly manipulated.This failure is likely due to factors or conditions related to the procedure that could have affected its performance and its intended purpose such as; the technique used by the customer during the procedure, not using vacuum during the removal process, the amount of strength applied to the device during the advance/ removal of it, and/or the interaction between the balloon and the scope.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 esophageal balloon dilation procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the balloon was deflated and the device was attempted to be pulled out from the endoscope; however, the device could not be removed.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.Investigation results revealed that the catheter was found broken in two sections; therefore, this is now an mdr reportable event.

• Brand Name: CRE FIXED WIRE
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road,; cork ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8705062
• MDR Text Key: 148203697
• Report Number: 3005099803-2019-02973
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 08714729195993
• UDI-Public: 08714729195993
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K971320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2020
• Device Model Number: M00558370
• Device Catalogue Number: 5837
• Device Lot Number: 0022608547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Date Manufacturer Received: 05/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1