FDA Adverse Event
Malfunction
Summary report: N
CATH PKGD: BERMAN 5 FR 5 0CM
MDR report key: 1011624
·
Received March 10, 2008
Report
- Report Number
- 2242445-2008-00007
- Event Type
- Malfunction
- Date Received
- March 10, 2008
- Date of Event
- February 22, 2008
- Report Date
- March 10, 2008
- Manufacturer
- ARROW INTL., INC.
- Product Code
- DQO
- PMA / PMN Number
- PREAMENDMENT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED, BY THE CLINICIAN, THAT THE BALLOON PRE-TESTED WITHOUT PROBLEMS AND WAS THEN INSERTED INTO THE PT. HOWEVER, WHEN THE BALLOON WAS CHECKED UNDER X-RAY, THE BALLOON WAS FOUND TO HAVE RUPTURED. AS A RESULT, THE BALLOON WAS EXCHANGED WITH A NEW ONE WITHOUT DIFFICULTY OR COMPLICATIONS TO THE PT. THE CLINICIAN NOTED THAT THERE WAS NO CALCIFICATION FOUND IN THE VESSEL THAT WOULD HAVE CAUSED THE RUPTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CATH PKGD: BERMAN 5 FR 5 0CM | BERMAN ANGIOGRAPHIC CATHETER PRODUCTS | DQO | ARROW INTL., INC. | HF7076357 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |