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

Model Number	M00558470
Medical Device Problem Codes	Entrapment of Device (1212); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Note: this report pertains to one of two cre wireguided dilatation balloons used during the same procedure.It was reported to boston scientific corporation that two cre wireguided dilatation balloons device were used in the duodenum during a duodenal dilation procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the black exit marker was noted to be bunched up like an accordion.It was also noted that it was squished and got wider which prevented the physician from moving the balloon at all.Reportedly, the device ended up lodged in the scope, so the balloon was removed together with the endoscope.The physician then cut the catheter in half with wire cutters to remove the device from the scope.They used a second cre wireguided dilatation balloon, and the same event occurred.The procedure was completed with a third cre wireguided dilatation balloon.There have been no patient complications as a result of this event.
Event or Problem Description
Note: this report pertains to one of two cre wireguided dilatation balloons used during the same procedure.It was reported to boston scientific corporation that two cre wireguided dilatation balloons device were used in the duodenum during a duodenal dilation procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the black exit marker was noted to be bunched up like an accordion.It was also noted that it was squished and got wider which prevented the physician from moving the balloon at all.Reportedly, the device ended up lodged in the scope, so the balloon was removed together with the endoscope.The physician then cut the catheter in half with wire cutters to remove the device from the scope.They used a second cre wireguided dilatation balloon, and the same event occurred.The procedure was completed with a third cre wireguided dilatation balloon.There have been no patient complications as a result of this event.
Additional Manufacturer Narrative
Problem code 2976 captures the reportable event of exit marker bunched up.A visual examination of the complaint device revealed that the black exit market was accordioned.It was noticed that the catheter was kinked and mechanically cut.The balloon did not show any damages.Dimensional examination of the catheter was performed and was measured in three sections; distal, medium and proximal.The three sections were within specification.This failure is likely due to factors or conditions related to procedure, the patient anatomy and/or the manner as the device was handled 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.

• Brand Name: CRE WIREGUIDED
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8439975
• Report Number: 3005099803-2019-01315
• Device Sequence Number: 1780464
• Product Code: FDT
• UDI-Device Identifier: 08714729339403
• UDI-Public: 08714729339403
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K110833
• 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: 01/31/2020
• Device Model Number: M00558470
• Device Catalogue Number: 5847
• Device Lot Number: 20304594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Initial Date Received by Manufacturer: 02/22/2019
• Supplement Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 03/21/2019
• 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