MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ALAIR¿; BRONCHIAL THERMOPLASTY SYSTEM

Model Number M005ATS25010

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Pneumothorax (2012)

Event Date 12/26/2017

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.The complainant indicated that the device was disposed and will not be returned for evaluation; 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 that an alair bronchial thermoplasty (bt) catheter was used during a bronchial thermoplasty procedure performed on (b)(6) 2017.On (b)(6) 2017 the patient underwent the first bronchial thermoplasty treatment performed in the right lower lobe of the lungs.No issues were noted with the device.Normal bloody sputum was noted during the procedure and the procedure was completed with no complications to the patient during or immediately following the bt treatment.The patient was given ddavp (desmopressin) pre and post operatively per hematology request without significant complications or concerns at that time.The patient went home and decreased their prednisone dose.The patient did not take any anticoagulation medications.The patient was in better health until (b)(6) 2017, when she began experiencing pulmonary symptoms of increased shortness of breath.Additionally, the patient experienced hemoptysis and coughed up a 300 cc bright red blood clot.The patient was admitted to the emergency room (er), and was then admitted to the intensive care unit (icu) after intubation.The patient was administered more ddavp and humate p, given by the local er prior to transfer to temple university health system.The patient was found to have bilateral pneumothoraces, and had chest tubes placed.The physician noted that this event was probably related to over-distention and aggressive bag mask ventilation in the local er prior to transfer.Bronchoscopy was performed and a blood clot was found throughout the airway (particularly right lower lobe).Initially the clot was suctioned, however bleeding was noticed in the airway, and the suctioning and bronchoscopy was stopped.The patient was stable for twelve hours following this bronchoscopy.At the 12th hour following the bronchoscopy, the patient began coughing, and coughed up 500 ccs of blood.Another bronchoscopy was performed, and another clot was noted to be in the airway.Some of the clot was removed by suction and ¿cryo¿.An endobronchial blocker was placed in the airway, the bleeding stopped for approximately 3 hours, and then the patient coughed up another 300 ccs of blood.After two days of intubation, the patient began to bleed again.A computerized tomography (ct) angiogram was negative for both bronchial artery aneurysm and extravasation of contrast.Two days later, the patient experienced more bleeding in the right lower lobe of the lungs.The patient was sent to interventional radiology, where the rll artery was embolized and the bleeding stopped.The patient was left intubated for 48 hours.Two days following embolization, the patient was extubated and the bleeding has since stopped.Total intubation time for this patient was seven days, and the patient was hospitalized for greater than two weeks in total.The patient is currently doing better, however the patient is reportedly still in the hospital.The physician assessed that the lung bleeding was significant and ¿definitely¿ related to the bt procedure.

• Brand Name: ALAIR¿
• Type of Device: BRONCHIAL THERMOPLASTY SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7244995
• MDR Text Key: 99133117
• Report Number: 3005099803-2018-00167
• Device Sequence Number: 1
• Product Code: OOY
• UDI-Device Identifier: 08714729802792
• UDI-Public: 08714729802792
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080032
• 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: 01/08/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: M005ATS25010
• Device Catalogue Number: ATS 2-5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2018
• Initial Date FDA Received: 02/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention
• Patient Age: 29 YR