MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2007-02-21 for WORLDPASS 2.0MM X 20MM 551220X manufactured by Cordis Europa, N.v..
[17038291]
The report we received from the affiliate indicated that the patient had severe stenosis on the distal-left anterior descending artery and the lesion was calcified. The physician engaged a vista brite tip guiding catheter and a runthrough (terumo) wire was advanced through the lesion. The physician chose a worldpass 2. 0 x 20mm to pre-dilate, but it was very difficult to withdraw the catheter back after pre-dilatation. Consequently, the physician removed the balloon catheter and used another worldpass. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[17284133]
The product is available for evaluation; however, as of to date it has not been returned. Additional information will be submitted within 30 days upon receipt. This device is distributed outside the united states; however, it is similar to the ptca balloon catheters distributed in united states.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610978-2007-00101 |
| MDR Report Key | 839225 |
| Report Source | 01,05,07 |
| Date Received | 2007-02-21 |
| Date of Report | 2007-01-30 |
| Date of Event | 2007-01-30 |
| Date Mfgr Received | 2007-01-30 |
| Device Manufacturer Date | 2006-09-01 |
| Date Added to Maude | 2007-04-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DR. THOMAS MORRISSEY, MED. DIRECTOR |
| Manufacturer Street | 14201 N.W. 60TH AVE. |
| Manufacturer City | MIAMI LAKES FL 33014 |
| Manufacturer Country | US |
| Manufacturer Postal | 33014 |
| Manufacturer Phone | 7863132516 |
| Manufacturer G1 | CORDIS EUROPA, N.V. |
| Manufacturer Street | P.O. BOX 38 |
| Manufacturer City | RODEN 9300AA |
| Manufacturer Country | NL |
| Manufacturer Postal Code | 9300 AA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WORLDPASS 2.0MM X 20MM |
| Generic Name | PTCA BALLOON CATHETERS (GBR) |
| Product Code | GBS |
| Date Received | 2007-02-21 |
| Model Number | NA |
| Catalog Number | 551220X |
| Lot Number | R0906391 |
| ID Number | PART#: NA |
| Device Expiration Date | 2008-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 826503 |
| Manufacturer | CORDIS EUROPA, N.V. |
| Manufacturer Address | * RODEN NL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-02-21 |