FDA Adverse Event
Malfunction
Summary report: N
SHERPA BALANCED 8F (JR4.0) GUIDE CATHETER
MDR report key: 2221811
·
Received August 17, 2011
Report
- Report Number
- 1220452-2011-00060
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- July 22, 2011
- Report Date
- August 9, 2011
- Manufacturer
- MEDTRONIC INC.
- Product Code
- DQY
- PMA / PMN Number
- K060418
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
EVALUATION IS ANTICIPATED UPON RECEIPT OF THE DISCREPANT DEVICE. AN ENGINEERING ANALYSIS OF THE SUBJECT DEVICE WILL E PERFORMED UPON RECEIPT.
Description of Event or Problem · 1
ON (B)(6) 2011 A LEFT SUBCLAVIAN STENTING WAS COMPLETED. THE PHYSICIAN, PROCEEDING WITH PRECAUTIOUS CORONARY INTERVENTION TRYING TO SEAT GUIDE, NOTICED GUIDE WAS FRACTURED UNDER FLUOROSCOPY. THE PHYSICIAN REMOVED ENTIRE GUIDE AND SHEATH FROM PT. CLASS ONE HEMATOMA NOTED TO RIGHT GROIN, THE PT BECAME HYPERTENSIVE, BRADYCARDIC ATROPINE GIVEN. PT DID NOT COMPLAIN OF ANY OTHER SYMPTOMS, TRANSFERRED CT SCANT TO RULE OUT RETRO CRANIAL BLEED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SHERPA BALANCED 8F (JR4.0) GUIDE CATHETER | DQY | MEDTRONIC INC. | NA | 0005303708 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |