MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLSTENT¿ ENTERAL ENDOPROSTHESIS; STENT, COLONIC, METALIC, EXPANDABLE

Model Number M00565590

Device Problem Material Perforation (2205)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4) sheath wire perforation.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) 2016 that a wallstent enteral stent was used during a procedure performed on an unknown date.According to the complainant, the physician was not able to deploy the stent.The stent system was examined outside the patient and it was noted that stent wires perforated the outer sheath of the delivery system.The procedure was completed with another wallstent enteral stent.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

A wallstent enteral stent and the delivery system were returned for analysis.Visual examination of the returned device found that the blue outer sheath was kinked near the proximal end of the device and several stent wires were found to have perforated the clear outer sheath near the distal end of the device.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 noted damage to the returned device was consistent with the application of excessive force being applied to the delivery system and is likely due to anatomical or procedural factors.Therefore, a review and analysis of all available information indicated that the most probable root cause is operational context.

Event Description

It was reported to boston scientific corporation on april 19, 2016 that a wallstent enteral stent was used during a procedure performed on an unknown date.According to the complainant, the physician was not able to deploy the stent.The stent system was examined outside the patient and it was noted that stent wires perforated the outer sheath of the delivery system.The procedure was completed with another wallstent enteral stent.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: WALLSTENT¿ ENTERAL ENDOPROSTHESIS
• Type of Device: STENT, COLONIC, METALIC, EXPANDABLE
• 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: 5654858
• MDR Text Key: 45197558
• Report Number: 3005099803-2016-01252
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K000281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/19/2016

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: 09/28/2017
• Device Model Number: M00565590
• Device Catalogue Number: 6559
• Device Lot Number: 0018455052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2016
• Initial Date FDA Received: 05/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2015
• 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