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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - COSTA RICA (COYOL) ALAIR¿; BRONCHIAL THERMOPLASTY SYSTEM Back to Search Results
Model Number M005ATS25010
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Date 03/14/2018
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.Atelectasis, study source- e7088 alair japan pms.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 as part of the e7088 alair japan pms clinical study.This complaint is being reported based on the event of atelectasis requiring treatment with antibiotics.On (b)(6) 2018 the patient underwent the third bronchial thermoplasty treatment performed on the right and left upper lobes of the lungs.No issues were noted with the device.According to the complainant, on (b)(6) 2018 the patient developed a 'small atelectasis' at the lingual segment of the lungs.Amoxicillin / clavulanate(ampc/cva) was prescribed.As of (b)(6) 2018 the event was resolved with no further patient complications reported.The patient's current condition is stable and the patient is expected to visit the facility on june 15, 2018 for followup.In the physician's assessment, it is unknown if the atelectasis was related to the bronchial thermoplasty treatement.
 
Event Description
It was reported to boston scientific corporation that an alair bronchial thermoplasty (bt) catheter was used during a bronchial thermoplasty procedure performed as part of the e7088 alair japan pms clinical study.This complaint is being reported based on the event of atelectasis requiring treatment with antibiotics.On (b)(6) 2018 the patient underwent the third bronchial thermoplasty treatment performed on the right and left upper lobes of the lungs.No issues were noted with the device.According to the complainant, on (b)(6) 2018 the patient developed a 'small atelectasis' at the lingual segment of the lungs.Amoxicillin / clavulanate(ampc/cva) was prescribed.As of (b)(6) 2018 the event was resolved with no further patient complications reported.The patient's current condition is stable and the patient is expected to visit the facility on (b)(6) 2018 for followup.In the physician's assessment, it is unknown if the atelectasis was related to the bronchial thermoplasty treatment.Additional information received on 15aug2018.On (b)(6) 2018 the patient recovered from the atelectasis.
 
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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 
MDR Report Key7532850
MDR Text Key108863215
Report Number3005099803-2018-01649
Device Sequence Number1
Product Code OOY
UDI-Device Identifier08714729802792
UDI-Public08714729802792
Combination Product (y/n)N
PMA/PMN Number
P080032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/25/2018
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 NumberM005ATS25010
Device Catalogue NumberATS 2-5
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/25/2018
Initial Date FDA Received05/22/2018
Supplement Dates Manufacturer Received08/15/2018
Supplement Dates FDA Received08/29/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age37 YR
Patient Weight85
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