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

Model Number M00558360

Device Problems Detachment Of Device Component (1104); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2014

Event Type  malfunction  

Event Description

It was reported to boston scientific that a cre fixed wire dilatation balloon was used in an esophageal dilation procedure on (b)(6), 2014.According to the complaint, during the procedure, the balloon ruptured and nothing detached within the patient.Dilation was sufficient, so the procedure was completed at this time.No sharp objects were reported to be in the area of dilatation.There were no patient complications reported as a result of this event.The patient's condition after the procedure was reported to be good.Investigation results revealed that the balloon was detached, therefore this is now a 30-day mdr reportable event.

Manufacturer Narrative

(b)(4).Visual examination of the device showed that the balloon was torn longitudinally and the balloon was detached from the catheter.Functional evaluation was not performed due to the damage of the device.Based on the condition of the returned device, this failure likely occurred due to anatomical/procedural factors which limited the performance of the balloon.Therefore, the most probable root cause is operational context.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? FIXED WIRE
• 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: 4711951
• MDR Text Key: 5736033
• Report Number: 3005099803-2015-00932
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• PMA/PMN Number: K971320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Model Number: M00558360
• Device Catalogue Number: 5836
• Device Lot Number: 0017302186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2014
• 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