MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK CRE? WIREGUIDED; DILATOR, ESOPHAGEAL

Model Number M00558500

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/09/2015

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a cre wire guided dilatation balloon was used during an esophageal dilation performed on (b)(6) 2015.According to the complainant, after the procedure was completed, the balloon was removed from the scope; however, the catheter was difficult to withdraw and the exit marker detached from the device within the scope.It was reported that nothing detached inside the patient.No visible issues were noted on the catheter.The procedure was completed with this device at this time.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

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.

Manufacturer Narrative

A visual examination of the complaint device revealed that the exit marker was bunched up.The catheter was noted to be kinked in multiple places; it was also cut near the distal end of the device.A functional examination could not be performed due to the condition of the device.Based on the condition of the returned device, the reported failure of exit marker detached was confirmed.It was reported that a vacuum was not maintained during insertion through the scope.It is likely that excessive force was used to overcome the resistance experienced during device advancement through the scope, which resulted in the exit marker becoming bunched up and loose, and the catheter becoming kinked.The directions for use (dfu) requires that a vacuum be applied to the balloon to maximize endoscopic passage of the balloon through the scope.Therefore, the most probable root cause is user/use error.

Event Description

It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used during an esophageal dilation performed on (b)(6) 2015.According to the complainant, after the procedure was completed, the balloon was removed from the scope; however, the catheter was difficult to withdraw and the exit marker detached from the device within the scope.It was reported that nothing detached inside the patient.No visible issues were noted on the catheter.The procedure was completed with this device at this time.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: CRE? WIREGUIDED
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 4573604
• MDR Text Key: 5552938
• Report Number: 3005099803-2015-00462
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110833
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: M00558500
• Device Catalogue Number: 5850
• Device Lot Number: 0017263717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2014
• 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