FDA Adverse Event
Injury
Summary report: N
WHISPER VIEW
MDR report key: 3052648
·
Received April 11, 2013
Report
- Report Number
- 2124215-2013-03897
- Event Type
- Injury
- Date Received
- April 11, 2013
- Date of Event
- February 28, 2012
- Report Date
- March 8, 2013
- Manufacturer
- EXTERNAL MANUFACTURER
- Product Code
- DQX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
- -
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
ADDITIONAL INFORMATION WAS OBTAINED. NO INTERVENTION WAS REQUIRED DUE TO THE PERFORATION AND THE LEADS WERE SUCCESSFULLY IMPLANTED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE, DURING THE CORONARY CANULATION, A PERFORATION OCCURRED. NO ADVERSE PATIENT EFFECTS WERE EXPERIENCED AS A RESULT OF THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 155378 | WHISPER VIEW | GUIDE WIRE | DQX | EXTERNAL MANUFACTURER | 4640 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Hospitalization| L| R | 1283| 0950| 4285| (B)(4)| 0465 |