MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRAFLEX TRACHEOBRONCHIAL; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number M00564520

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/06/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem 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) 2022 that an ultraflex tracheobronchial uncovered distal release stent was to be implanted in the trachea to treat a 2cm malignant bronchial stenosis during a stent implantation procedure performed on (b)(6) 2022.During the procedure, the stent deployment suture broke.The stent was removed from the patient partially deployed on the delivery system.The procedure was not completed due to this event.There were no patient complications reported due to this event.The patient condition at the conclusion of the procedure was reported to be stable.

Event Description

It was reported to boston scientific corporation on january 27, 2022 that an ultraflex tracheobronchial uncovered distal release stent was to be implanted in the trachea to treat a 2cm malignant bronchial stenosis during a stent implantation procedure performed on (b)(6) 2022.During the procedure, the stent deployment suture broke.The stent was removed from the patient partially deployed on the delivery system.The procedure was not completed due to this event.There were no patient complications reported due to this event.The patient condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h6: impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: an ultraflex tracheobroncial uncovered distal release stent, delivery system and stylet were received for analysis; the black deployment suture was not returned.Visual examination of the returned device found the shaft was bent and cut.The stent was returned fully deployed.However, a media inspection was performed of a photo provided by the customer and it was observed that the stent was partially deployed.No other problems were noted to the stent and delivery system.The investigation concluded that the reported event and the observed failures were likely due to procedural factors, such as handling and manipulation of the device and the used of excessive force against significant resistance during the procedure ,which limited the performance of the device and contributed to shaft bent and stent partially deployed.Additionally, the shaft was cut, most likely.The shaft was intentionally cut during the procedure to help remove the stent from the scope as the stent was observed to be partially deployed.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• Brand Name: ULTRAFLEX TRACHEOBRONCHIAL
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13569061
• MDR Text Key: 286884714
• Report Number: 3005099803-2022-00792
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K012883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2022
• Device Model Number: M00564520
• Device Catalogue Number: 6452
• Device Lot Number: 0026463582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2020
• 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 Age: 72 YR
• Patient Sex: Male
• Patient Weight: 75 KG