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

Model Number M00565060

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).Investigation results: a fully constrained wallflex colonic stent and delivery system was received for analysis.Visual examination of the returned device found the handle¿s stainless steel tube kinked and there was slight bunching proximal to the stent¿s proximal end.A functional analysis noted that it was possible to deploy the stent until the kink on the stainless steel tube was encountered.A wire on the flared end of the stent was found to be broken.There were no other issues were identified during the product analysis.The investigation did not confirm the reported complaint of stent failed to deploy.However, extra force required to deploy the stent was confirmed.Taking this into consideration, along with the condition of the returned device, the investigation concluded that the observed failures are likely due to anatomical/ procedural factors encountered during the procedure which limited the performance of the device.Therefore, the most probable root cause for this complaint is operational context.A review of the device history record (dhr) revealed no non-conforming events or deviations.A search of the complaint database confirmed that no similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation that a wallflex colonic stent was to be used in the colon during a stent placement procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the stent failed to deploy.Reportedly, a great amount of force was used in attempting to deploy the stent.The procedure was completed with another wallflex colonic 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.Note: this event has been deemed an mdr-reportable event based on investigation results which revealed that a wire on the flared end of the stent was broken.

• Brand Name: WALLFLEX¿ COLONIC
• 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: 6589458
• MDR Text Key: 75930921
• Report Number: 3005099803-2017-01527
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 08714729456537
• UDI-Public: (01)08714729456537(17)20180504(10)0019107700
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K061877
• 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: 05/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/05/2018
• Device Model Number: M00565060
• Device Catalogue Number: 6506
• Device Lot Number: 0019107700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2016
• 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