FDA Adverse Event
Other
Summary report: N
AORTIC OCCLUSION CATHETER
MDR report key: 246162
·
Received October 26, 1999
Report
- Report Number
- 1056436-1999-00177
- Event Type
- Other
- Date Received
- October 26, 1999
- Date of Event
- September 28, 1999
- Report Date
- October 1, 1999
- Manufacturer
- HORIZON MEDICAL PRODUCTS, INC.
- Product Code
- MJN
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- SERVICE PERSONNEL
Narratives
Description of Event or Problem · 1
ON 10/01/1999, THE INTERNATIONAL DISTRIBUTOR INFORMED THE MFR VIA A FAXED REPORT OF THE FOLLOWING: THIS DOCTOR REPORTED THAT HE EXPERIENCED THE SAME DEFECT WITH THE SAME ITEM AND LOT NUMBER. AFTER INFLATION OF THE BALLOON WITH (NALL) SALINE, THE BALLOON BURST AND MANY FLAKES FROM THE RUBBER ARISE. IN BOTH CASES, NON-ATHEROSCLEROSIS WAS FOUND. THE OPERATIONS WERE ELECTIVE, NON-EMERGENCY PROCEDURES NEEDED. A "FLAKE" OF THE BALLOON WAS SCHEDULED TO BE RETURNED TO THE MFR FOR ANALYSIS. NO FURTHER DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AORTIC OCCLUSION CATHETER | CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY | MJN | HORIZON MEDICAL PRODUCTS, INC. | NA | I092398-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |