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

Model Number	M00576570
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis; however the analysis has not yet been completed.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 or Problem Description
It was reported to boston scientific corporation that a ultraflex tracheobronchial stent 14x30 was to be used to treat a malignancy in the left main stem of the trachea during a stent implantation procedure on (b)(6) 2020.According to the complainant, during the procedure and after the stent was deployed, the physician noticed that one of the struts was broken and the wire was poking out.Reportedly, for the patient's safety, the physician decided to remove the stent with rat tooth forceps.As the stent was being removed, the stent got stuck in the laryngeal mask airway.The stent was replaced with another ultraflex tracheobronchial stent 14x30 stent from the shelf.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
Additional Manufacturer Narrative
Block h6: device problem code 1069 captured the report event of stent break.Block h10: the returned ultraflex tracheobronchial stent was analyzed, and a visual evaluation noted that the stent was returned inside a non-boston scientific laryngeal mask airway product.The stent was inspected and no damages were noted.A dimensional evaluation noted that the device was measured within specification.No other issues with the device were noted.The stent was returned in a non-boston scientific laryngeal mask airway product; therefore, device interaction with another device is confirmed.Stent break could not be confirmed as there was no damage to the stent.All wires and sutures of the stent were returned in good condition.Therefore, a review and analysis of all available information indicated that the most probable root cause is no problem detected.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a ultraflex tracheobronchial stent 14x30 was to be used to treat a malignancy in the left main stem of the trachea during a stent implantation procedure on (b)(6) 2020.According to the complainant, during the procedure and after the stent was deployed, the physician noticed that one of the struts was broken and the wire was poking out.Reportedly, for the patient's safety, the physician decided to remove the stent with rat tooth forceps.As the stent was being removed, the stent got stuck in the laryngeal mask airway.The stent was replaced with another ultraflex tracheobronchial stent 14x30 stent from the shelf.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: ULTRAFLEX TRACHEOBRONCHIAL
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9747227
• Report Number: 3005099803-2020-00513
• Device Sequence Number: 16637638
• Product Code: JCT
• UDI-Device Identifier: 08714729842378
• UDI-Public: 08714729842378
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K141584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/20/2021
• Device Model Number: M00576570
• Device Catalogue Number: 7657
• Device Lot Number: 0023825280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 03/14/2020
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 04/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention