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 2020-03-26 for BLAZER II HTD 85060 manufactured by Boston Scientific Corporation.
[185205584]
Event date is estimated. 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 medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[185205585]
It was reported that the catheter packaging contained foreign material. Prior to an ablation procedure, before opening up the package of a blazer ii htd ablation catheter, a "red-fluff" like particle was noticed within the unopened package of the device making it a non-sterile product. The "red fluff" was noted near the deflection wing on the handle. The device was never opened and a new catheter was pulled off the shelf and used for the procedure. No patient complications occurred. The device is expected for analysis but has not been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03932 |
| MDR Report Key | 9884748 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-01 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2019-12-09 |
| Date Added to Maude | 2020-03-26 |
| 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 | TIMOTHY DEGROOT |
| Manufacturer Street | 4100 HAMLINE AVENUE NORTH DC A330 |
| Manufacturer City | SAINT PAUL MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 6515826168 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | 302 PARKWAY, GLOBAL PARK |
| Manufacturer City | LA AURORA - HEREDIA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLAZER II HTD |
| Generic Name | CARDIAC ABLATION PERCUTANEOUS CATHETER |
| Product Code | LPB |
| Date Received | 2020-03-26 |
| Model Number | 85060 |
| Catalog Number | 85060 |
| Lot Number | 0024899637 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-26 |