MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2013-04-02 for TYSHAK II CATHETER 105 PDC501 manufactured by Numed Canada, Inc..
[16551795]
The balloon ruptured at 4. 0 atm. Nominal pressure 4. 5 atm and rated burst pressure 6. 0 atm.
Patient Sequence No: 1, Text Type: D, B5
[16774227]
A clean longitudinal burst was confirmed when the catheter was received. This typically is from over pressurization. Two samples catheters were pulled from inventory and tested for rated burst pressure. Labeled nominal pressure is 4. 5 atm, and rated burst pressure is 6. 0 atm. The first catheter was taken to rbp of 6. 0 atm and left on pressure for 3 minutes. It was then taken up to burst, which was 10. 0 atm. It was a clean longitudinal burst. The second catheter was taken to rbp of 6. 0 atm and left on pressure for 3 minutes. It was then taken up to 8 atm and left on pressure. It ended up bursting at 8 atm after being on pressure for over 1. 5 minutes. It was also a clean longitudinal burst. Numed could not duplicate this balloon burst. Cause of the burst is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9618000-2013-00001 |
| MDR Report Key | 3256969 |
| Report Source | 01,05,08 |
| Date Received | 2013-04-02 |
| Date of Report | 2013-04-02 |
| Date of Event | 2013-02-20 |
| Date Mfgr Received | 2013-03-12 |
| Device Manufacturer Date | 2011-02-28 |
| Date Added to Maude | 2013-08-06 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS NICHELLE LAFLESH |
| Manufacturer Street | 45 SECOND ST. W |
| Manufacturer City | CORNWALL, ONTARIO K6J 1G3 |
| Manufacturer Country | CA |
| Manufacturer Postal | K6J 1G3 |
| Manufacturer Phone | 3284491 |
| Manufacturer G1 | NUMED CANADA, INC. |
| Manufacturer Street | 45 SECOND ST. W. |
| Manufacturer City | CORNWALL, ONTARIO K6J1G3 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | K6J 1G3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TYSHAK II CATHETER |
| Generic Name | PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER |
| Product Code | OMZ |
| Date Received | 2013-04-02 |
| Returned To Mfg | 2013-03-12 |
| Model Number | 105 |
| Catalog Number | PDC501 |
| Lot Number | TH-15144 |
| Device Expiration Date | 2016-02-28 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUMED CANADA, INC. |
| Manufacturer Address | 45 SECOND ST. W CORNWALL, ONTARIO K6J1G3 CA K6J 1G3 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-02 |