MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-04-26 for CRE? PULMONARY M00550350 5035 manufactured by Boston Scientific - Costa Rica (coyol).
[106839644]
The complainant was unable to provide the lot number. Therefore, the manufacture and expiration dates are unknown. It was reported the device was not used past its expiry date. (b)(4). According to the complainant, the suspect device has been disposed and is not available for return. If any further relevant information is received, a supplemental mdr will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[106839645]
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was used in the trachea during a bronchoscopy with balloon dilation procedure performed on (b)(6) 2018. According to the complainant, the balloon was noted to be kinked after being inflated for the first time. A second attempt to inflate the balloon was made but the balloon did not inflate anymore. The procedure was completed with another cre pulmonary dilatation balloon. There were no patient complications reported as a result of this event. The patient's condition after the procedure was reported to be fine. Attempts to obtain additional patient and procedure information have been unsuccessful. If any further relevant information is received, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-01403 |
| MDR Report Key | 7465197 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-04-26 |
| Date of Report | 2018-04-05 |
| Date of Event | 2018-04-05 |
| Date Mfgr Received | 2018-04-05 |
| Date Added to Maude | 2018-04-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EMP. NANCY CUTINO |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834000 |
| Manufacturer G1 | BOSTON SCIENTIFIC - COSTA RICA (COYOL) |
| Manufacturer Street | 2546 FIRST STREET PROPARK FREE ZONE |
| Manufacturer City | ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRE? PULMONARY |
| Generic Name | BRONCHOSCOPE ACCESSORY |
| Product Code | KTI |
| Date Received | 2018-04-26 |
| Model Number | M00550350 |
| Catalog Number | 5035 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - COSTA RICA (COYOL) |
| Manufacturer Address | 2546 FIRST STREET PROPARK FREE ZONE ALAJUELA CS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-26 |