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 15MM 551120X manufactured by Cordis Europa, N.v..
[598200]
As the 2. 0 x 15 mm worldpass balloon was inflated to 8 atm in the mid left anterior descending (lad) vessel the balloon suddenly ruptured. The physician withdrew it at once and another balloon catheter was used to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
[7870420]
The product is available for evaluation and testing; however, it has not been received to date (which is indicated as "other"). Additional information will be submitted within 30 days of 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 | 9610978-2007-00102 |
| MDR Report Key | 839305 |
| Report Source | 01,05,07 |
| Date Received | 2007-02-21 |
| Date of Report | 2007-01-23 |
| Date of Event | 2007-01-23 |
| Date Mfgr Received | 2007-01-23 |
| Device Manufacturer Date | 2006-10-01 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WORLDPASS 2.0MM X 15MM |
| Generic Name | PTCA BALLOON CATHETERS (GBR) |
| Product Code | GBS |
| Date Received | 2007-02-21 |
| Model Number | NA |
| Catalog Number | 551120X |
| Lot Number | R1006112 |
| ID Number | PART#: NA |
| Device Expiration Date | 2008-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 826596 |
| Manufacturer | CORDIS EUROPA, N.V. |
| Manufacturer Address | * RODEN NL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-02-21 |