MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY ULTRAFLEX¿ TRACHEOBRONCHIAL; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number M00564890

Device Problem Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2018 that an ultraflex tracheobronchial covered distal release stent was to be used to treat a malignant stenosis in the airway during a stent placement procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the stent was able to be deployed but was not fully expanded.The stent was removed with forceps and another ultraflex tracheobronchial stent was used to complete the procedure.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.

Event Description

It was reported to boston scientific corporation on july 6, 2018 that an ultraflex tracheobronchial covered distal release stent was to be used to treat a malignant stenosis in the airway during a stent placement procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the stent was able to be deployed but was not fully expanded.The stent was removed with forceps and another ultraflex tracheobronchial stent was used to complete the procedure.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

A deployed and expanded ultraflex tracheobronchial covered distal release stent was received for analysis; the delivery system was not returned.Visual examination identified no issues with the stent.The stent was measured to be within specifications.The analysis of the returned device could not confirm the reported event that the stent failed to expand; however, a photo of the device provided by the complainant shows a stent that was not fully expanded.This confirms the reported event.Taking all available information into consideration, the reported event was likely due to anatomical/ procedural factors encountered during the procedure, which limited the performance of the device.Therefore, the most probable root cause is operational context.A labeling review was performed, and from the information available, this device was used per the directions for use (dfu) / product label.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 revealed that no other similar complaints exist for the specified batch.

• Brand Name: ULTRAFLEX¿ TRACHEOBRONCHIAL
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7726698
• MDR Text Key: 115237876
• Report Number: 3005099803-2018-02361
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• PMA/PMN Number: K012883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2018
• Device Model Number: M00564890
• Device Catalogue Number: 6489
• Device Lot Number: 19972335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Initial Date Manufacturer Received: 07/06/2018
• Initial Date FDA Received: 07/27/2018
• Supplement Dates Manufacturer Received: 09/17/2018
• Supplement Dates FDA Received: 10/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 56