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

Model Number M00576570

Device Problems Break (1069); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2019

Event Type  Injury  

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 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.

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 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
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9747227
• MDR Text Key: 188654704
• Report Number: 3005099803-2020-00513
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 08714729842378
• UDI-Public: 08714729842378
• Combination Product (y/n): N
• PMA/PMN Number: K141584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention