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

Model Number M00564800

Device Problems Positioning Problem (3009); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2017

Event Type  Injury  

Manufacturer Narrative

(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 an ultraflex tracheobronchial distal release stent was to be used to treat a malignant stricture in the left principal bronchus during a stent placement procedure performed on (b)(6) 2017.Reportedly, the patient's anatomy was tight.According to the complainant, during the procedure, the physician was able to fully deploy the stent, however, the stent failed to expand to the needed diameter causing it to slipped out of the target site.The stent was removed from the patient using a forceps and the procedure was completed with another ultraflex tracheobrochial 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.

Manufacturer Narrative

Investigation results: a partially deployed ultraflex tracheobronchial stent and delivery system was returned for analysis.Functional evaluation of the returned device found that the shaft bowed during deployment but it was possible to deploy the stent as received.No issues noted with the stent and no other issues were noted with the device.Device analysis determined that the condition of the returned device confirms the reported event that the stent was partially deployed and is likely due to anatomical or procedural factors, such as tight anatomy, 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 similar complaints exist for the specified lot.Corrected information received on august 3, 2017: block updated.

Event Description

It was reported to boston scientific corporation on june 16, 2017 that an ultraflex tracheobronchial distal release stent was to be used to treat a malignant stricture in the left principal bronchus during a stent placement procedure performed on (b)(6) 2017.Reportedly, the patient's anatomy was tight.According to the complainant, during the procedure, the physician was able to fully deploy the stent, however, the stent failed to expand to the needed diameter causing it to slipped out of the target site.The stent was removed from the patient using a forceps and the procedure was completed with another ultraflex tracheobrochial 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.Corrected information received on august 3, 2017.The complainant reported that the stent was not fully deployed.The stent was partially deployed and could not be released further and slipped off the target site.

• Brand Name: ULTRAFLEX¿ TRACHEOBRONCHIAL
• Type of Device: PROSTHESIS, TRACHEAL, 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: 6691044
• MDR Text Key: 79210444
• Report Number: 3005099803-2017-01929
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K012883
• 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: 06/16/2017

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: 05/10/2018
• Device Model Number: M00564800
• Device Catalogue Number: 6480
• Device Lot Number: 19239735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2017
• Initial Date FDA Received: 07/06/2017
• Supplement Dates Manufacturer Received: 08/02/2017
• Supplement Dates FDA Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Weight: 53