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 Problem Bacterial Infection (1735)

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.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 the alair bronchial thermoplasty (bt) catheter was used during a patient¿s bronchial thermoplasty treatments.According to the complainant, this patient event was reported during a ¿conference presentation p6-3.¿ the patient underwent the first bronchial thermoplasty procedure performed in the right lower lobe of the lungs.The exact procedure date was not reported.The patient underwent the second bronchial thermoplasty procedure performed in the left lower lobe of the lungs.The exact procedure date was not reported.The patient underwent the third bronchial thermoplasty procedure performed in the right and left upper lobes of the lungs.The exact procedure date was not reported.No issues were noted to the alair bt catheters used during these procedures.According to the complainant, following the first bt procedure, aspergillus fumigatus and nocardia species was confirmed on the bronchial mucosa.Additionally, the patient experienced a dry cough.Oral administration of voriconazole was administered for seven months to treat the bronchial aspergillus.The patient was administered medication of st mixture (timethoprim-sulfamethoxazole) for three months to treat the nocardia.Following the second bt procedure, a white ulcerative lesion was observed in the patient.When bronchial abrasion and bronchial biopsy were performed from the same site, aspergillus fumigatus was detected.Administration of voriconazole was performed for bronchial aspergillosis for a total of seven months.Following the third bt procedure, nocardia species was detected from sputum that had been suctioned from the patient during the procedure.The patient was administered medication of st mixture (timethoprim-sulfamethoxazole) for three months.Approximately seven months following the bt treatment, the patient underwent computerized tomography (ct).The ct scan showed a new infiltration shadow around the lower right lobe bronchus which caused the bronchial infection.Bronchoscopy was performed again.In the biopsy tissue, occluded bronchiolitis with eosinophil infiltration was in the biopsy tissue, no findings suggestive of infection were observed, and no significant bacteria were detected in the culture.Twelve months following the bt treatment, the infiltration shadow disappeared.The physician noted the patient seems to be in a state susceptible to infection by continuous steroid internal administration and perioperative steroid administration.Additionally, the treating physician stated that there was possibility that the respiratory tract mucosa may have been damaged, and respiratory tract infection occurred.There was no reported treatment for the suspected tissue damage.Refer to manufacturer report # 3005099803-2018-01919 for the events associated with the patient¿s first bt treatment.Refer to this manufacturer report for the events associated with the patient¿s second bt treatment.Refer to manufacturer report # 3005099803-2018-01920 for the events associated with the patient¿s third bt treatment.

• 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: 7613751
• MDR Text Key: 111471951
• Report Number: 3005099803-2018-01918
• Device Sequence Number: 1
• Product Code: OOY
• UDI-Device Identifier: 08714729802792
• UDI-Public: 08714729802792
• Combination Product (y/n): N
• PMA/PMN Number: P080032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/24/2018

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: 05/24/2018
• Initial Date FDA Received: 06/19/2018
• 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): Required Intervention
• Patient Age: 36 YR