MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK ALAIR¿; BRONCHIAL THERMOPLASTY SYSTEM

Model Number M005ATS25010

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

Patient Problem Pneumonia (2011)

Event Date 07/31/2017

Event Type  Injury  

Manufacturer Narrative

The exact age of the patient was not reported, however, the patient was reported to be over 18 years old.The device has been received for analysis.Upon 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 that an alair bt (bronchial thermoplasty) catheter was used during a bronchial thermoplasty procedure performed on (b)(6) 2017.Prior to undergoing the second bt treatment, the patient was admitted to the hospital as planned for an arthroplasty procedure (exact date not reported).Following the arthroplasty procedure, the patient remained in the hospital for treatment of his disease state (no details provided).On (b)(6) 2017 the patient underwent the second bt treatment performed in the right and left upper lobes of the lungs.The physician noted that the second bt treatment was performed in the upper lobes because the patient had pre-existing pulmonary atelectasis in the left lower lobe.According to the complainant, during the bt procedure, after completing 11 activations with the bt catheter, the catheter handle icon flashed red on the alair bt controller.The catheter was promptly removed from the patient, although upon removal from the patient, the physician found that the thermocouple (tc) wire had become separated but did not detach from the electrode array.No pieces of the device fell off into the patient.Minor bleeding approximately 10ml was noted at the treatment site and the patient was administered thrombin for hemostasis.No additional forms of treatment were required.Following, the bronchial thermoplasty procedure, the patient developed aspiration pneumonia (onset date not reported).The patient was administered methylprednisolone and an antibiotic to treat the pneumonia.The patient¿s current condition is reported to be ¿stable¿ and the patient is expected to undergo the third bt procedure in the left lower lobe depending on the condition of the pulmonary atelectasis.

Manufacturer Narrative

A visual evaluation of the returned device was performed.The device was inspected for defects along the catheter handle and shaft.No damage was noted.The electrode array was visually inspected in both the relaxed state and expanded states.The yellow tc wire was found separated but not completely detached from its solder pad.A functional test was performed and the catheter handle icon flashed red.A labeling review was performed and from the information available, this device was used per the directions for use (dfu) / product label.The dfu list pneumonia as an adverse event that may occur with the use of this device.The adverse event of pneumonia may occur during the treatment phase (from first bronchoscopy until 6 weeks after final bronchoscopy) or in the first year post-treatment.Therefore, the most probable root cause classification for the reported event of pneumonia is anticipated procedural complication.A review of the device history record (dhr) revealed no non-conforming events or deviations.A similar complaint search was performed and found no similar complaints.

Event Description

It was reported to boston scientific corporation that an alair bt (bronchial thermoplasty) catheter was used during a bronchial thermoplasty procedure performed on (b)(6) 2017.Prior to undergoing the second bt treatment, the patient was admitted to the hospital as planned for an arthroplasty procedure (exact date not reported).Following the arthroplasty procedure, the patient remained in the hospital for treatment of his disease state (no details provided).On (b)(6) 2017 the patient underwent the second bt treatment performed in the right and left upper lobes of the lungs.The physician noted that the second bt treatment was performed in the upper lobes because the patient had pre-existing pulmonary atelectasis in the left lower lobe.According to the complainant, during the bt procedure, after completing 11 activations with the bt catheter, the catheter handle icon flashed red on the alair bt controller.The catheter was promptly removed from the patient, although upon removal from the patient, the physician found that the thermocouple (tc) wire had become separated but did not detach from the electrode array.No pieces of the device fell off into the patient.Minor bleeding approximately 10ml was noted at the treatment site and the patient was administered thrombin for hemostasis.No additional forms of treatment were required.Following, the bronchial thermoplasty procedure, the patient developed aspiration pneumonia (onset date not reported).The patient was administered methylprednisolone and an antibiotic to treat the pneumonia.The patient¿s current condition is reported to be ¿stable¿ and the patient is expected to undergo the third bt procedure in the left lower lobe depending on the condition of the pulmonary atelectasis.

• Brand Name: ALAIR¿
• Type of Device: BRONCHIAL THERMOPLASTY SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6817233
• MDR Text Key: 83510221
• Report Number: 3005099803-2017-02598
• Device Sequence Number: 1
• Product Code: OOY
• UDI-Device Identifier: 08714729802792
• UDI-Public: (01)08714729802792(17)20190430(10)20506882
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: P080032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/01/2017

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: Physician
• Device Expiration Date: 04/30/2019
• Device Model Number: M005ATS25010
• Device Catalogue Number: ATS 2-5
• Device Lot Number: 20506882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2017
• Initial Date FDA Received: 08/24/2017
• Supplement Dates Manufacturer Received: 09/17/2017
• Supplement Dates FDA Received: 10/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2017
• 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): Required Intervention