N
Patient 1
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
MAUDE MDR 7086732
- MDR report key
- 7086732
- Report number
- 1416980-2017-09596
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-08-02
- Date received
- 2017-12-06
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Address
- 25212 W. ILLINOIS ROUTE 120 ROUND LAKE IL 60073 US
- Phone
- 224-224-2242
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | VASCULAR PROBES | DILATOR, VESSEL, SURGICAL | SYNOVIS SURGICAL INNOVATIONS | DWP | NA | 7451015ES | SP17F271237184 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-12-06 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THERE WAS PARTICULATE MATTER IN THE INNER POUCH OF SIX (6) VASCULAR PROBES. THIS WAS NOTED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
N
Patient 1
SIX DEVICES WERE RECEIVED FOR EVALUATION. DURING VISUAL EXAMINATION, LOOSE PARTICULATE MATTER (PM) WAS PRESENT ON THE OUTSIDE WALL OF THE INNER POUCH FOR TWO UNITS, AND ON THE INSIDE WALL OF THE INNER POUCH FOR FOUR UNITS. MICROSCOPIC INSPECTION WAS PERFORMED AND THE LOOSE PM WAS DETERMINED TO BE FIBER FOR FIVE OF THE UNITS, AND A PARTICLE FOR ONE UNIT. THE FIBERS WERE MEASURED AND FOUR WERE DETERMINED TO BE LESS THAN 0.80MM? AND THIS UNIT MEETS SPECIFICATION. THE PARTICLE WAS DETERMINED TO BE LESS THAN 0.80MM? AND THEREFORE THIS UNIT MEETS SPECIFICATION. THE REPORTED CONDITION WAS NOT VERIFIED. ONE FIBER WAS DETERMINED TO BE LARGER THAN 0.80 MM? AND THEREFORE THIS UNIT DOES NOT MEET SPECIFICATION. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION WAS DUE TO AN UNKNOWN MANUFACTURING PROCESS. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
D
Patient 1