ALAIR BRONCHIAL THERMOPLASTY CATHETER
Report
- Report Number
- 3005099803-2011-04618
- Event Type
- Injury
- Date Received
- January 10, 2012
- Date of Event
- December 14, 2011
- Report Date
- December 15, 2011
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- OOY
- PMA / PMN Number
- P080032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE 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.
(B)(4).
MFR NAME: BOSTON SCIENTIFIC CORPORATION (B)(4). STUDY: (B)(4).
(B)(4).
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BRONCHIAL THERMOPLASTY CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY (BT) PROCEDURE ON (B)(6) 2011, AS PART OF (B)(4) CLINICAL STUDY. ACCORDING TO THE COMPLAINANT, DURING THE PATIENT'S THIRD BT PROCEDURE, THE PATIENT EXPERIENCED AN EVENT OF ASTHMA EXACERBATION. THE PATIENT DEVELOPED A SEVERE COUGH DURING AND AFTER THE PROCEDURE THAT DID NOT IMMEDIATELY RESOLVE. ON THE DAY FOLLOWING THE PROCEDURE, THE PATIENT'S CONDITION WORSENED AND THE PATIENT WAS BROUGHT TO THE EMERGENCY ROOM ON (B)(6) 2011, AND SUBSEQUENTLY ADMITTED. THE PATIENT WAS TREATED WITH PAIN MEDICATIONS AND STEROIDS (DETAILS NOT REPORTED). THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011; THE DURATION OF THE HOSPITALIZATION WAS 7 DAYS. THE ASTHMA EVENT HAS BEEN REPORTED AS CONTINUING. THE PROCEDURE WAS COMPLETED WITH THE SAME CATHETER WITH NO DEVICE MALFUNCTIONS REPORTED.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BRONCHIAL THERMOPLASTY CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY (BT) PROCEDURE ON (B)(6), 2011, AS PART OF THE (B)(6). ACCORDING TO THE COMPLAINANT, DURING THE PATIENT'S THIRD BT PROCEDURE, THE PATIENT EXPERIENCED AN EVENT OF ASTHMA EXACERBATION. THE PATIENT DEVELOPED A SEVERE COUGH DURING AND AFTER THE PROCEDURE THAT DID NOT IMMEDIATELY RESOLVE. ON THE DAY FOLLOWING THE PROCEDURE, THE PATIENT'S CONDITION WORSENED AND THE PATIENT WAS BROUGHT TO THE EMERGENCY ROOM ON (B)(6), 2011, AND SUBSEQUENTLY ADMITTED. THE PATIENT WAS TREATED WITH PAIN MEDICATIONS AND STEROIDS (DETAILS NOT REPORTED). THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011; THE DURATION OF THE HOSPITALIZATION WAS 7 DAYS. THE ASTHMA EVENT HAS BEEN REPORTED AS CONTINUING. THE PROCEDURE WAS COMPLETED WITH THE SAME CATHETER WITH NO DEVICE MALFUNCTIONS REPORTED. (B)(6), 2012: FOLLOW UP, CONDUCTED SIX WEEKS FOLLOWING THE PROCEDURE, INDICATED THAT THE PATIENT CONTINUED TO HAVE CHEST TIGHTNESS, SHORTNESS OF BREATH AND NIGHTTIME EXACERBATIONS. PEAK FLOWS WERE ALSO REPORTED AS STILL BELOW BASELINE 6 WEEKS POST PROCEDURE. (B)(6), 2012: THE FIRST EVENT OF ASTHMA AGGRAVATED FOLLOWING THE THIRD BT PROCEDURE WAS REPORTED AS CONTINUING WITH RESIDUAL EFFECTS AT THE 6 WEEK FOLLOW UP. THE PATIENT HAD SYMPTOMS OF SHORTNESS OF BREATH AND CHEST TIGHTNESS. PEAK FLOWS WERE REPORTED AS BELOW BASELINE, AND THE PATIENT HAS SOME NIGHTTIME EXACERBATIONS. ON (B)(6), 2012, THE PATIENT EXPERIENCED A SECOND EVENT OF ASTHMA AGGRAVATED WITH SYMPTOMS OF COUGH AND INCREASED SHORTNESS OF BREATH. THE PATIENT WAS TREATED WITH AN ADDITIONAL PULSE OF STEROIDS (A TAPERING DOSE OF PREDNISONE), AND THE EVENT WAS REPORTED AS RESOLVED ON (B)(6), 2012. THERE WERE NO EMERGENCY ROOM VISITS OR HOSPITALIZATIONS REPORTED WITH THIS SECOND EVENT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BRONCHIAL THERMOPLASTY CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY (BT) PROCEDURE ON (B)(6), 2011, AS PART OF THE (B)(4) CLINICAL STUDY. ACCORDING TO THE COMPLAINANT, DURING THE PATIENT'S THIRD BT PROCEDURE, THE PATIENT EXPERIENCED AN EVENT OF ASTHMA EXACERBATION. THE PATIENT DEVELOPED A SEVERE COUGH DURING AND AFTER THE PROCEDURE THAT DID NOT IMMEDIATELY RESOLVE. ON THE DAY FOLLOWING THE PROCEDURE, THE PATIENT'S CONDITION WORSENED AND THE PATIENT WAS BROUGHT TO THE EMERGENCY ROOM ON (B)(6), 2011, AND SUBSEQUENTLY ADMITTED. THE PATIENT WAS TREATED WITH PAIN MEDICATIONS AND STEROIDS (DETAILS NOT REPORTED). THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011; THE DURATION OF THE HOSPITALIZATION WAS 7 DAYS. THE ASTHMA EVENT HAS BEEN REPORTED AS CONTINUING. THE PROCEDURE WAS COMPLETED WITH THE SAME CATHETER WITH NO DEVICE MALFUNCTIONS REPORTED. UPDATE (B)(4), 2012: FOLLOW UP, CONDUCTED SIX WEEKS FOLLOWING THE PROCEDURE, INDICATED THAT THE PATIENT CONTINUED TO HAVE CHEST TIGHTNESS, SHORTNESS OF BREATH AND NIGHTTIME EXACERBATIONS. PEAK FLOWS WERE ALSO REPORTED AS STILL BELOW BASELINE 6 WEEKS POST PROCEDURE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BRONCHIAL THERMOPLASTY CATHETER WAS USED DURING A BRONCHIAL THERMOPLASTY (BT) PROCEDURE ON (B)(6) 2011, AS PART OF THE (B)(6) STUDY. ACCORDING TO THE COMPLAINANT, DURING THE PATIENT'S THIRD BT PROCEDURE, THE PATIENT EXPERIENCED AN EVENT OF ASTHMA EXACERBATION. THE PATIENT DEVELOPED A SEVERE COUGH DURING AND AFTER THE PROCEDURE THAT DID NOT IMMEDIATELY RESOLVE. ON THE DAY FOLLOWING THE PROCEDURE, THE PATIENT'S CONDITION WORSENED AND THE PATIENT WAS BROUGHT TO THE EMERGENCY ROOM ON (B)(6), 2011, AND SUBSEQUENTLY ADMITTED. THE PATIENT WAS TREATED WITH PAIN MEDICATIONS AND STEROIDS (DETAILS NOT REPORTED). THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011; THE DURATION OF THE HOSPITALIZATION WAS 7 DAYS. THE ASTHMA EVENT HAS BEEN REPORTED AS CONTINUING. THE PROCEDURE WAS COMPLETED WITH THE SAME CATHETER WITH NO DEVICE MALFUNCTIONS REPORTED. ***UPDATE (B)(6) 2012*** FOLLOW UP, CONDUCTED SIX WEEKS FOLLOWING THE PROCEDURE, INDICATED THAT THE PATIENT CONTINUED TO HAVE CHEST TIGHTNESS, SHORTNESS OF BREATH AND NIGHTTIME EXACERBATIONS. PEAK FLOWS WERE ALSO REPORTED AS STILL BELOW BASELINE 6 WEEKS POST PROCEDURE. ***UPDATE (B)(6) 2012*** THE FIRST EVENT OF ASTHMA AGGRAVATED FOLLOWING THE THIRD BT PROCEDURE WAS REPORTED AS CONTINUING WITH RESIDUAL EFFECTS AT THE 6 WEEK FOLLOW UP. THE PATIENT HAD SYMPTOMS OF SHORTNESS OF BREATH AND CHEST TIGHTNESS. PEAK FLOWS WERE REPORTED AS BELOW BASELINE, AND THE PATIENT HAS SOME NIGHTTIME EXACERBATIONS. ON (B)(6) 2012, THE PATIENT EXPERIENCED A SECOND EVENT OF ASTHMA AGGRAVATED WITH SYMPTOMS OF COUGH AND INCREASED SHORTNESS OF BREATH. THE PATIENT WAS TREATED WITH AN ADDITIONAL PULSE OF STEROIDS (A TAPERING DOSE OF PREDNISONE), AND THE EVENT WAS REPORTED AS RESOLVED ON (B)(6) 2012. THERE WERE NO EMERGENCY ROOM VISITS OR HOSPITALIZATIONS REPORTED WITH THIS SECOND EVENT. **UPDATE (B)(6) 2013*** THE REPORTED EVENT OF ASTHMA EXACERBATION THAT BEGAN ON (B)(6) 2011 RESOLVED ON (B)(6) 2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALAIR BRONCHIAL THERMOPLASTY CATHETER | ELECTROSURGICAL, BRONCHIAL THERMOPLASTY CATHETER & SYSTEM & ACCESSORIES | OOY | BOSTON SCIENTIFIC - MARLBOROUGH | M005ATS25010 | 021010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Hospitalization |