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

Model Number M00564850

Device Problems Break (1069); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2019 that an ultraflex tracheobronchial distal release covered stent was to be used in the trachea to treat a stenosis in the airway due to malignant tumor compression during a stenting procedure performed on (b)(6) 2019.Reportedly, the patient's anatomy was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was deployed but it did not reach the target lesion.The physician clamped the blue stent retention suture with forceps and adjust the position of the stent, however; the stent retenstion suture broke.The stent was removed from the patient and another ultraflex tracheobronchial stent was placed to complete the procedure.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

Block e1: initial reporter address: (b)(6).Block h6: problem code 1069 captures the repotable event of stent suture break.Problem code 3009 captures the reportable event of stent positioning issue.Block h10: an ultraflex tracheobronchial covered stent was received for analysis; the delivery system was not returned.Visual analysis of the returned device found the stent was deployed, unraveled and expanded.One of the green retention suture was not returned and the other retention suture was present and no anomalies were noted.The stent was measured to be within specifications.No other issues with the stent were noted.The detachment of the green retention suture was consistent with the reported event, resulting in excessive force being applied during the attempt to reposition the stent with forceps.In addition, the retention suture is not intended to be used for repositioning.Taking all available information into consideration, the investigation concluded that interaction between the user and the device, caused or contributed to the event.Therefore, the most probable root cause is unintended use error caused or contributed to event.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 labeling review was performed, and from the information available, this device was used per the directions for use (dfu) / product label.

Event Description

It was reported to boston scientific corporation on august 16, 2019 that an ultraflex tracheobronchial distal release covered stent was to be used in the trachea to treat a stenosis in the airway due to malignant tumor compression during a stenting procedure performed on (b)(6) 2019.Reportedly, the patient's anatomy was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was deployed but it did not reach the target lesion.The physician clamped the blue stent retention suture with forceps and adjust the position of the stent, however; the stent retenstion suture broke.The stent was removed from the patient and another ultraflex tracheobronchial stent was placed to complete the procedure.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.

• 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: 8967472
• MDR Text Key: 156734731
• Report Number: 3005099803-2019-04378
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• PMA/PMN Number: K012883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: M00564850
• Device Catalogue Number: 6485
• Device Lot Number: 0022452665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2019
• Date Manufacturer Received: 09/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 60