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 2020-02-05 for OPTICROSS HD 8668 manufactured by Boston Scientific Corporation.
[179240404]
(b)(6). Device evaluated by mfr: the device was returned for analysis. Device analysis revealed that the device has a hole that leaked in the lap joint section and due to this condition the catheter was unable to flush normally. On high magnification was possible to note a detachment in the lap joint section. However, the lap joint section was measured and the dimension was found within specification.
Patient Sequence No: 1, Text Type: N, H10
[179240405]
Reportable based on device analysis completed on 13jan2020. It was reported that saline leaked from the connection part occurred. An opticross hd imaging catheter was selected for use. During procedure, saline leaked from the connection part between the blue and transparent parts of the shaft. The procedure was competed with another of the same device. No patient complications were reported. However, device analysis revealed a detachment in the lap joint section.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-00987 |
| MDR Report Key | 9671626 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-05 |
| Date of Event | 2019-11-27 |
| Date Mfgr Received | 2020-01-13 |
| Device Manufacturer Date | 2019-08-27 |
| Date Added to Maude | 2020-02-05 |
| 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 | JAY JOHNSON JOHNSON |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634942574 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | 2546 CALLE PRIMERA |
| Manufacturer City | ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTICROSS HD |
| Generic Name | CATHETER, ULTRASOUND, INTRAVASCULAR |
| Product Code | OBJ |
| Date Received | 2020-02-05 |
| Returned To Mfg | 2019-12-14 |
| Model Number | 8668 |
| Catalog Number | 8668 |
| Lot Number | 0024335212 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | TWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-05 |