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

Model Number M00576530

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2018

Event Type  Injury  

Manufacturer Narrative

Problem code captures the reportable event of stent failed to expand.Problem code captures the reportable event of stent positioning/ placement problem.Conclusion code is being used in lieu of an adequate conclusion code for device not returned.According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

Note: this report pertains to one of the two devices used during the same procedure.Refer to manufacturer report # 3005099803-2018-60988 and 3005099803-2018-60989 for the associated device information.It was reported to boston scientific corporation on (b)(6) 2018 that two ultraflex tracheobronchial covered distal release stents were to be used to treat a malignant stricture due to a tumor in the airway during a pulmonary stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was dilated prior to stent placement.According to the complainant, during the procedure, the stent deployment suture was released, but the first ultraflex tracheobronchial stent (the subject of this report) would not expand.It was reported that the plastic lumen on the stent would not open and remained compressed against the catheter.Reportedly, the stent ended up deploying "too high up" and was not deployed in the proper location.The physician removed the stent with forceps.A second ultraflex tracheobronchial stent (the subject of mfr.Report # 3005099803-2018-60989) was used, but the same issue had occurred.The procedure was completed with another ultraflex tracheobronchial stent of different size.There were no patient complications reported.The patient's condition following 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
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8005614
• MDR Text Key: 125020616
• Report Number: 3005099803-2018-60988
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 08714729842330
• UDI-Public: 08714729842330
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/25/2018

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: 02/16/2020
• Device Model Number: M00576530
• Device Catalogue Number: 56598
• Device Lot Number: 0021754433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2018
• Initial Date FDA Received: 10/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2018
• 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