FDA Adverse Event
Malfunction
Summary report: N
SELECTRA MPH-45
MDR report key: 6824833
·
Received August 28, 2017
Report
- Report Number
- 1028232-2017-02984
- Event Type
- Malfunction
- Date Received
- August 28, 2017
- Date of Event
- August 1, 2017
- Report Date
- August 22, 2017
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- DQY
- PMA / PMN Number
- K110461
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.
Description of Event or Problem · 1
THIS SELECTRA WAS USED DURING A CASE ON (B)(6) 2017. DURING THE CASE WHEN THE PHYSICIAN WAS SLITTING/REMOVING THE SHEATH, ABOUT 3 INCHES OR SO WAS LEFT IN THE PATIENT. THE PHYSICIAN CALLED IN TWO DIFFERENT CARDIAC SURGEONS WHO AGREED THAT IT WAS BETTER TO LEAVE THE 3 INCHES OF SHEATH INSIDE THE PATIENT INSTEAD OF TRYING TO REMOVE IT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 604181 | SELECTRA MPH-45 | CATHETER | DQY | BIOTRONIK SE & CO. KG | 375533 | 05167509 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Other |