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

Model Number M00558380

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation results a visual examination of the complaint device revealed that the catheter was cut into two sections; both sections of the device were returned.It was also noted that the balloon material was detached from the proximal bond and was torn longitudinally.This failure is likely due to anatomical/procedural factors encountered during the procedure which limited the performance of the device.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.A search of the complaint database revealed that no other complaints exist for the specified lot.(b)(4).

Event Description

It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was used in the sigmoid colon during a gastroscopy procedure performed on (b)(6) 2017.According to the complainant, during the procedure, when the physician tried to increase the pressure the balloon burst.The balloon was removed and the procedure was completed with another cre fixed wire dilatation balloon device.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 stable.Investigation results revealed that the balloon material detached from the proximal bond; therefore, this is now an mdr reportable event.

• 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: 7303987
• MDR Text Key: 101274178
• Report Number: 3005099803-2018-00479
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: SE
• PMA/PMN Number: K971320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2019
• Device Model Number: M00558380
• Device Catalogue Number: 5838
• Device Lot Number: 20569006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2017
• 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
• Patient Age: 72 YR