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

Model Number M00564780

Device Problem Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on january 17, 2020 that an ultraflex tracheobronchial covered distal release stent was to be used to treat tracheostenosis during a tracheal stent implantation procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the stent was able to be deployed; however, the stent was unable to fully expand to cure the lesion.Reportedly, the physician attempted to re-sheath the stent but it was unsuccessful.The stent was removed unexpanded on the delivery system and another ultraflex tracheobronchial stent was used 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 h6: device problem code 3270 captures the reportable event of stent failure to expand.Block h10: investigation results an ultraflex tracheobronchial covered distal stent and delivery system were received for analysis.The stent was received fully deployed.Visual examination of the returned device did not find any damages to the stent and delivery system.The stent was measured to be within specifications.The reported event of stent failure to expand was not confirmed; the stent was received deployed and fully expanded.Taking all available information into consideration, the device met all manufacturing specifications required and passed all the controls and inspections with no abnormalities were reported during the assembly process.Therefore, the most probable cause is no problem detected.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.Block h11: blocks d4 (lot number and expiration date) and h4 (manufacture date) have been corrected based on the additional information received on march 31, 2020.

Event Description

It was reported to boston scientific corporation on (b)(6) 2020 that an ultraflex tracheobronchial covered distal release stent was to be used to treat tracheostenosis during a tracheal stent implantation procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the stent was able to be deployed; however, the stent was unable to fully expand to cure the lesion.Reportedly, the physician attempted to re-sheath the stent but it was unsuccessful.The stent was removed unexpanded on the delivery system and another ultraflex tracheobronchial stent was used 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: 9695904
• MDR Text Key: 190358835
• Report Number: 3005099803-2020-00383
• 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: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/27/2018
• Device Model Number: M00564780
• Device Catalogue Number: 6478
• Device Lot Number: 0019523588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Initial Date Manufacturer Received: 01/17/2020
• Initial Date FDA Received: 02/11/2020
• Supplement Dates Manufacturer Received: 03/31/2020
• Supplement Dates FDA Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 68