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

Model Number M00564780

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/19/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complainant indicated that the ultraflex tracheobronchial stent was retained and will not be returned for evaluation; therefore, a device 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 july 21, 2022 that an ultraflex tracheobronchial covered distal release stent was implanted in the bronchi to treat a bronchial stenosis during a tracheobronchial stenting procedure performed on (b)(6) 2022.During the procedure, the ultraflex tracheobronchial stent was deployed; however, the physician noticed that the upper part of the stent was broken.The stent remains implanted and the procedure was completed.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.However, the patient remained in the hospital and was under observation.Note: no further information has been obtained despite good faith efforts.

Manufacturer Narrative

Blocks b1, b2 (outcomes attrib to adv event), b5, e1 (initial reporter address 1, state, zip/postal code), h6 (impact code) and h10.Block h6: medical device problem code a0401 captures the reportable event of stent break.Block h10: the complainant indicated that the ultraflex tracheobronchial stent remained implanted and will not be returned for evaluation; therefore, a device 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 july 21, 2022 that an ultraflex tracheobronchial covered distal release stent was implanted in the bronchi to treat a bronchial stenosis during a tracheobronchial stenting procedure performed on (b)(6), 2022.During the procedure, the ultraflex tracheobronchial stent was deployed; however, the physician noticed that the upper part of the stent was broken.The stent remains implanted and the procedure was completed.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.However, the patient remained in the hospital and was under observation.Additional information received on august 9, 2022 and august 10, 2022.It was reported that the ultraflex tracheobroncial stent was implanted to treat a 3cm malignant bronchial stenosis.The patient's anatomy was not tortuous and was dilated prior to stent placement.It was during postoperative tracheoscopy that the upper end of the ultraflex tracheobronchial stent was found broken.Observation was done as a normal routine every after procedure.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15190272
• MDR Text Key: 305600348
• Report Number: 3005099803-2022-04483
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K012883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2023
• Device Model Number: M00564780
• Device Catalogue Number: 6478
• Device Lot Number: 0027627188
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2021
• 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): Hospitalization
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 70 KG