BRONCHIAL THERMOPLASTY CATHETER
Report
- Report Number
- 3005099803-2013-01218
- Event Type
- Injury
- Date Received
- February 28, 2013
- Date of Event
- January 28, 2013
- Report Date
- February 1, 2013
- Manufacturer
- BOSTON SCIENTIFIC - CORK
- Product Code
- OOY
- PMA / PMN Number
- P080032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4).
(B)(4).
(B)(6). (B)(4). A VISUAL AND FUNCTIONAL EXAMINATION OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL SPECIFICATION REQUIREMENTS, ALLOWING IT TO BE RELEASED FOR DISTRIBUTION. A LABELING REVIEW WAS PERFORMED AND FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED IN ACCORDANCE WITH THE LABELING. UPPER RESPIRATORY TRACT INFECTION AND ASTHMA EXACERBATION ARE LISTED IN THE DIRECTIONS FOR USE (DFU) AS POTENTIAL ADVERSE EVENTS THAT MAY OCCUR. THEREFORE, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS ANTICIPATED PROCEDURAL COMPLICATION.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BRONCHIAL THERMOPLASTY CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE ON (B)(6) 2013 AS PART OF THE (B)(4) STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF UPPER RESPIRATORY TRACT INFECTION TREATED WITH ANTIBIOTICS. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT HER THIRD BRONCHIAL THERMOPLASTY TREATMENT TO THE RIGHT AND LEFT UPPER LOBES ON (B)(6) 2013. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ISSUES NOTED. FOLLOWING THE PROCEDURE ON (B)(6) 2013, THE PATIENT EXPERIENCED AN EVENT OF ASTHMA EXACERBATION. THE PATIENT COMPLAINED OF WHEEZE IMMEDIATELY POST-PROCEDURE AND COUGH WHICH DEVELOPED THE EVENING OF THE PROCEDURE. THE PATIENT BEGAN SELF TREATING WITH XOPENEX AND TESSALON PERLES WERE PRESCRIBED FOR THE COUGH. ON (B)(6) 2013, THE PATIENT VISITED THE EMERGENCY ROOM FOR WORSENING OF COUGH. THE PATIENT WAS DIAGNOSED WITH AN UPPER RESPIRATORY TRACT INFECTION (URTI) WITH AN ONSET DATE OF (B)(6) 2013. THE PATIENT WAS TREATED WITH LEVAQUIN. NO HOSPITALIZATIONS OCCURRED AS A RESULT OF THIS EVENT. BASELINE SPIROMETRY VALUES: VISIT DATE: (B)(6) 2012 PRE-BRONCHODILATOR FEV1: 1.78 FEV1 % PREDICTED: 74.79 FVC: 2.18 FVC % PREDICTED: 72.19 POST-BRONCHODILATOR FEV1: 2.13 FEV1 % PREDICTED: 89.50 FVC: 2.71 FVC % PREDICTED: 89.74 **ADDITIONAL INFORMATION RECEIVED SINCE (B)(6) 2013** ACCORDING TO THE COMPLAINANT, THE UPPER RESPIRATORY TRACT INFECTION (URTI) WAS CONSIDERED RESOLVED AS OF (B)(6) 2013. **ADDITIONAL INFORMATION RECEIVED AS OF (B)(6) 2013 ** ACCORDING TO THE COMPLAINANT, THE EVENT OF ASTHMA EXACERBATION WAS CONSIDERED RESOLVED AS OF (B)(6) 2013.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BRONCHIAL THERMOPLASTY CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE ON (B)(6), 2013 AS PART OF THE (B)(4). THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF UPPER RESPIRATORY TRACT INFECTION TREATED WITH ANTIBIOTICS. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT HER THIRD BRONCHIAL THERMOPLASTY TREATMENT TO THE RIGHT AND LEFT UPPER LOBES ON (B)(6) 2013. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ISSUES NOTED. FOLLOWING THE PROCEDURE ON (B)(6) 2013, THE PATIENT EXPERIENCED AN EVENT OF ASTHMA EXACERBATION. THE PATIENT COMPLAINED OF WHEEZE IMMEDIATELY POST-PROCEDURE AND COUGH WHICH DEVELOPED THE EVENING OF THE PROCEDURE. THE PATIENT BEGAN SELF TREATING WITH XOPENEX AND TESSALON PERLES WERE PRESCRIBED FOR THE COUGH. ON (B)(6) 2013, THE PATIENT VISITED THE EMERGENCY ROOM FOR WORSENING OF COUGH. THE PATIENT WAS DIAGNOSED WITH AN UPPER RESPIRATORY TRACT INFECTION (URTI) WITH AN ONSET DATE OF (B)(6) 2013. THE PATIENT WAS TREATED WITH LEVAQUIN. NO HOSPITALIZATIONS OCCURRED AS A RESULT OF THIS EVENT. BASELINE SPIROMETRY VALUES: VISIT DATE: (B)(6) 2012. PRE-BRONCHODILATOR: FEV1: 1.78, FEV1 % PREDICTED: 74.79, FVC: 2.18, FVC % PREDICTED: 72.19. POST-BRONCHODILATOR: FEV1: 2.13, FEV1 % PREDICTED: 89.50, FVC: 2.71, FVC % PREDICTED: 89.74. ADDITIONAL INFORMATION RECEIVED SINCE (B)(4) 2013: ACCORDING TO THE COMPLAINANT, THE UPPER RESPIRATORY TRACT INFECTION (URTI) WAS CONSIDERED RESOLVED AS OF (B)(6) 2013.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALAIR BRONCHIAL THERMOPLASTY CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY PROCEDURE ON (B)(6) 2013 AS PART OF THE (B)(4) STUDY. THIS COMPLAINT IS BEING REPORTED BASED ON THE EVENT OF UPPER RESPIRATORY TRACT INFECTION TREATED WITH ANTIBIOTICS. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT HER THIRD BRONCHIAL THERMOPLASTY TREATMENT TO THE RIGHT AND LEFT UPPER LOBES ON (B)(6) 2013. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ISSUES NOTED. FOLLOWING THE PROCEDURE ON (B)(6) 2013, THE PATIENT EXPERIENCED AN EVENT OF ASTHMA EXACERBATION. THE PATIENT COMPLAINED OF WHEEZE IMMEDIATELY POST-PROCEDURE AND COUGH WHICH DEVELOPED THE EVENING OF THE PROCEDURE. THE PATIENT BEGAN SELF TREATING WITH XOPENEX AND TESSALON PERLES WERE PRESCRIBED FOR THE COUGH. ON (B)(6) 2013, THE PATIENT VISITED THE EMERGENCY ROOM FOR WORSENING OF COUGH. THE PATIENT WAS DIAGNOSED WITH AN UPPER RESPIRATORY TRACT INFECTION (URTI) WITH AN ONSET DATE OF (B)(6) 2013. THE PATIENT WAS TREATED WITH LEVAQUIN. NO HOSPITALIZATIONS OCCURRED AS A RESULT OF THIS EVENT. BASELINE SPIROMETRY VALUES: VISIT DATE: (B)(6) 2012. PRE-BRONCHODILATOR: FEV1: 1.78, FEV1 % PREDICTED: 74.79, FVC: 2.18, FVC % PREDICTED: 72.19. POST-BRONCHODILATOR: FEV1: 2.13, FEV1 % PREDICTED: 89.50, FVC: 2.71, FVC % PREDICTED: 89.74.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 87488 | BRONCHIAL THERMOPLASTY CATHETER | BRONCHIAL THERMOPLASTY SYSTEM | OOY | BOSTON SCIENTIFIC - CORK | M005ATS25010 | CM-082012-038 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |