MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY ULTRAFLEX? ESOPHAGEAL NG; PROSTHESIS, ESOPHAGEAL

Model Number M00513750

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2014

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an ultraflex esophageal distal release stent was used in the esophagus during a esophageal stenting procedure performed on (b)(6) 2014.According to the complainant, this was to treat an 8cm lesion due to malignancy.Reportedly, the patient's anatomy was pre dilated.During unpacking, it as found that the catheter was kinked.The device was not used and the procedure was completed with another ultraflex esophageal distal release stent.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.This event has been deemed reportable based on the investigation results that the stent was partially deployed.

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.(b)(4) for the investigation result of stent partially deployed.Investigation results a visual examination of the returned device showed that the stent was partially deployed by 26mm.The pulling had been removed from the hub and the deployment thread had been retracted to partially deploy the stent.It was also noted that the device was received with a mandrel inserted.A visual and tactile examination found that the stent and the catheter of the device were kinked.These damages may have been caused by handling during the removal of packaging and with excessive force being applied to the delivery system and may have occurred during the handling of the device.Based on the condition of the returned device, this investigation is assigned the most probable root cause classification of handling damage.The deployment thread had been retracted to partially deploy the stent and the device would not have been in this condition when unpacked.The complaint was caused by handling of the device or portion of the device without direct patient contact either during unpacking, preparation, shipping; at the end of the procedure; or when packaging for return.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

• Brand Name: ULTRAFLEX? ESOPHAGEAL NG
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 4330257
• MDR Text Key: 5243053
• Report Number: 3005099803-2014-03929
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K091816
• 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: 11/24/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2016
• Device Model Number: M00513750
• Device Catalogue Number: 1375
• Device Lot Number: 0016695508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2014
• Initial Date FDA Received: 12/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1