MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-05-29 for PNEUMATIC INFLATOR M00553200 5320 manufactured by Boston Scientific Corporation.
[146368672]
Date of event: date of event was approximated to (b)(6) 2019 as no event date was reported. The complainant was unable to provide the serial number. Therefore, the manufacture date is unknown. (b)(4). The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[146368673]
It was reported to boston scientific corporation that a pneumatic inflator was used during a procedure performed on an unknown date. According to the complainant, the pressure on the gauge does not go back to zero. There have been no patient complications reported as a result of this event. Attempts to obtain additional information regarding this event have been unsuccessful to date. Should additional relevant details become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-02758 |
| MDR Report Key | 8649913 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-29 |
| Date of Report | 2019-09-17 |
| Date of Event | 2019-05-01 |
| Date Mfgr Received | 2019-08-22 |
| Device Manufacturer Date | 2014-12-01 |
| Date Added to Maude | 2019-05-29 |
| 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 | CAROLE MORLEY |
| Manufacturer Street | 300 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | NAVILYST MEDICAL |
| Manufacturer Street | 10 GLENS FALLS TECHNICAL PARK |
| Manufacturer City | GLENS FALLS NY 12801 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PNEUMATIC INFLATOR |
| Generic Name | CATHETER, BALLOON TYPE |
| Product Code | GBA |
| Date Received | 2019-05-29 |
| Returned To Mfg | 2019-07-03 |
| Model Number | M00553200 |
| Catalog Number | 5320 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-29 |