FDA Adverse Event
Malfunction
Summary report: N
OPTIGUIDE FIBER OPTIC DIFFUSER, DCYL SERIES
MDR report key: 8866481
·
Received August 6, 2019
Report
- Report Number
- 3010119152-2019-00002
- Event Type
- Malfunction
- Date Received
- August 6, 2019
- Date of Event
- November 2, 2017
- Report Date
- August 6, 2019
- Manufacturer
- PINNACLE BIOLOGICS, INC.
- Product Code
- MVG
- UDI-DI
- 00376128000063
- PMA / PMN Number
- P940010
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
PDT IS A NON-THERMAL TREATMENT FOR CERTAIN TYPES OF CANCERS. THE INVESTIGATION DETERMINED THAT THE INVESTIGATOR HAD USED FORCE WHEN INSERTING THE FIBER THROUGH THE BRONCHOSCOPE. REVIEW OF THE BATCH RECORDS BY THE MANUFACTURER INDICATES THAT THE FIBER MET ALL SPECIFICATIONS AT THE TIME OF RELEASE.
Description of Event or Problem · 1
PATIENT WAS ENROLLED IN A CLINICAL STUDY TO EVALUATE THE SAFETY AND TISSUE RESPONSE TO PHOTODYNAMIC THERAPY USING PORFIMER SODIUM FOR INJECTION AS A TREATMENT FOR SOLID LUNG TUMORS PRIOR TO SURGICAL RESECTION. THE SURGEON FOUND A PIECE OF THE FIBER OPTIC IN THE TUMOR POST-RESECTION. THIS CASE CORRESPONDS TO THE FOLLOWING PINNACLE BIOLOGICS INC. ICSR#: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 660342 | OPTIGUIDE FIBER OPTIC DIFFUSER, DCYL SERIES | FIBER OPTIC DIFFUSER | MVG | PINNACLE BIOLOGICS, INC. | DCYL740 | 5662301 | 00376128000063 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |