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

Model Number M00564800

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2020

Event Type  Injury  

Manufacturer Narrative

(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 medwatch will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2020 that an ultraflex tracheobronchial covered distal release stent was to be implanted in the left main bronchus during a tracheobronchial stent implantation procedure performed on (b)(6) 2020.According to the complainant, after the stent was implanted, the wire at the proximal end of the stent was fractured.The stent was removed from the patient and another ultraflex tracheobronchial stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h6: problem code 1069 captures the reportable event of stent suture break.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: 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 medwatch will be filed.Block h11: block g1 (manufacturer contact zip/postal code) and block e1 (initial reporter city and post code) have been corrected.

Event Description

It was reported to boston scientific corporation on september 24, 2020 that an ultraflex tracheobronchial covered distal release stent was to be implanted in the left main bronchus during a tracheobronchial stent implantation procedure performed on (b)(6) 2020.According to the complainant, after the stent was implanted, the wire at the proximal end of the stent was fractured.The stent was removed from the patient and another ultraflex tracheobronchial stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Blocks e1 (initial reporter's title, first and last name, phone number), and e3 (occupation) have been updated with additional information received on october 19, 2020.Block h6: problem code 1069 captures the reportable event of stent suture break.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: 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 medwatch will be filed.

Event Description

It was reported to boston scientific corporation on september 24, 2020 that an ultraflex tracheobronchial covered distal release stent was to be implanted in the left main bronchus during a tracheobronchial stent implantation procedure performed on (b)(6) 2020.According to the complainant, after the stent was implanted, the wire at the proximal end of the stent was fractured.The stent was removed from the patient and another ultraflex tracheobronchial stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.The patient 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: 10687155
• MDR Text Key: 211641541
• Report Number: 3005099803-2020-04695
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 10/19/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2020
• Device Model Number: M00564800
• Device Catalogue Number: 6480
• Device Lot Number: 0022734117
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/24/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 09/24/2020; 09/24/2020
• Supplement Dates FDA Received: 10/19/2020; 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 55