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

Model Number M00514210

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4) stent partially deployed.The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2015 that an ultraflex esophageal ng distal release covered stent was to be used in the esophagus during a gastro procedure performed on (b)(6) 2015.According to the complainant, this was to treat a malignant stricture.Reportedly, the patient's anatomy was not pre dilated.During the procedure, after the physician partially deployed the stent, it was noted that the stent could no longer deploy further.The partially deployed stent was then removed from the patient and the procedure was completed with a different 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.

Manufacturer Narrative

An ultraflex¿ esophageal ng stent and delivery system were returned for analysis.Visual examination of the returned device found that the stent was partially deployed.A visual examination found the deployment suture past the most distal crochet knot was pinched between the stent wires at the distal end of the stent.The deployment suture appeared to catch and pull on the stent when pulled.Device analysis revealed that it was possible to deploy the stent once the deployment suture was extracted from between the stent wires.No other issues were identified during the product analysis.Device analysis determined that the condition of the returned device was consistent with the complaint incident.The cause of the noted device defect was most probably due to anatomical or procedural factors encountered during the procedure.Therefore, the most probable root cause for this complaint is operational context.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 search of the complaint database confirmed that no other complaints exist for the specified batch.

Event Description

It was reported to boston scientific corporation on (b)(6) 2015 that an ultraflex esophageal ng distal release covered stent was to be used in the esophagus during a gastro procedure performed on (b)(6) 2015.According to the complainant, this was to treat a malignant stricture.Reportedly, the patient's anatomy was not pre dilated.During the procedure, after the physician partially deployed the stent, it was noted that the stent could no longer deploy further.The partially deployed stent was then removed from the patient and the procedure was completed with a different 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.

• Brand Name: ULTRAFLEX¿ ESOPHAGEAL NG
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5320246
• MDR Text Key: 34169330
• Report Number: 3005099803-2015-03618
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K091816
• 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,Followup
• Report Date: 12/03/2015

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: 08/20/2017
• Device Model Number: M00514210
• Device Catalogue Number: 1421
• Device Lot Number: 18320209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2015
• Initial Date FDA Received: 12/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2015
• 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