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 07/14/2014

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used during a balloon stricture dilation procedure in the colon performed on (b)(6) 2014.According to the complainant, during the procedure, the cre balloon was unable to pass over the wire through the scope.The balloon was then removed and inflated with water outside the patient and deflated to try and advance the device over the wire, but they still were unable to pass the device through the wire.The procedure was completed with another cre balloon.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 the exit marker to be loose and wrinkled on the catheter, therefore this is now an mdr reportable event.

Manufacturer Narrative

Investigation results of exit marker loose and wrinkled.A visual examination of the complaint device revealed the balloon to be relaxed and deflated.The catheter shaft had two kinks.The exit marker was found to be loose and wrinkled on the catheter.A test guide wire was inserted into the guide wire lumen and it exited through the distal tip with no resistance.This issue of the exit marker is consistent with either catheter difficulty advancing through the scope or catheter difficulty removing from the scope.It was confirmed that a vacuum was not applied to the balloon before protective sleeve removal which is against the dfu.The catheter kink most likely occurred during forcible catheter advancement over the guide wire and through the scope.The most probable root cause of user/use error will be assigned to this complaint as it was confirmed that there was an act or omission of an act that could have resulted in difficulty passing the device over the guide wire.The device history record review confirms that this device met all material, assembly and performance specifications.A review for similar complaints was completed and there were no other complaints reported.

• 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: 4081321
• MDR Text Key: 4828324
• Report Number: 3005099803-2014-02961
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K110833
• 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: 08/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Model Number: M00558500
• Device Catalogue Number: 5850
• Device Lot Number: 15816141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2013
• 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: 55 YR