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 07/05/2017

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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) 2017 that a wallflex enteral colonic stent was to be used in the sigmoid flexure of the colon to treat a stenosis due to dysplasia during an unknown procedure performed on (b)(6) 2017.According to the complainant, during the procedure, it was reported that the delivery catheter was broken when trying to deliver the stent in the stenosis area.The procedure was completed with another wallflex enteral 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.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

Manufacturer Narrative

Updated with the additional information received on august 18, 2017.A fully constrained wallflex enteral colonic stent and delivery system was returned for analysis.Visual examination of the returned device found that the blue outer sheath was detached from the white deployment handle and was broken.The inner shaft was broken just distal to the stainless steel tube.In addition, the clear outer sheath was buckled at the proximal end of the stent.Functional analysis found the stent was possible to deploy manually.There was no issue with the stent and no other issues were identified during the product analysis.The noted damages to the returned device were consistent with the application of excessive force during attempted deployment and are likely due to anatomical or procedural factors, which limited the performance of the device.Therefore, a review and analysis of all available information indicated that the most probable root cause is operational context.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.A search of the complaint database confirmed that no other similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation on (b)(6) 2017 that a wallflex enteral colonic stent was to be used in the sigmoid flexure of the colon to treat a stenosis due to dysplasia during an unknown procedure performed on (b)(6) 2017.According to the complainant, during the procedure, it was reported that the delivery catheter was broken when trying to deliver the stent in the stenosis area.The procedure was completed with another wallflex enteral 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.Additional information received on august 18, 2017.The wallflex enteral colonic stent was to be used to treat a stenosis due to malignant colorectal obstruction.Reportedly, the patient's anatomy was tortuous and was ¿probably not¿ dilated prior to stent placement.According to the complainant, during the procedure, the delivery system was difficult to pass through the lesion, and the delivery system broke near the distal end of the catheter during deployment.

• 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: 6774711
• MDR Text Key: 82074414
• Report Number: 3005099803-2017-02418
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 08714729456537
• UDI-Public: (01)08714729456537(17)20190329(10)20462107
• Combination Product (y/n): N
• Reporter Country Code: ES
• 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,Followup
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2019
• Device Model Number: M00565060
• Device Catalogue Number: 6506
• Device Lot Number: 20462107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2017
• 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