MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-11-10 for TYSHAK PDC017 610534 manufactured by B. Braun Medical Inc..
[534142]
As reported by the user facility: while performing a valvuloplasty procedure, they were applying negative pressure to the balloon. The physician noted a hole in the balloon, removed the balloon system from the body and used a new balloon. Add'l info provided by the facility indicated the pt suffered no adverse sequela associated with the incident.
Patient Sequence No: 1, Text Type: D, B5
[7984129]
The actual device in the incident was returned to the mfr for eval. One used catheter was returned. The balloon appeared intact and visual examination did not reveal a hole in the balloon. These balloon catheters are mfg and purchased from numed, inc. The sample and all available info has been forwarded to numed for eval. If numed's eval reveals any add'l info, a follow-up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523676-2006-00088 |
| MDR Report Key | 780563 |
| Report Source | 06 |
| Date Received | 2006-11-10 |
| Date of Report | 2006-10-30 |
| Date of Event | 2006-08-29 |
| Date Mfgr Received | 2006-08-31 |
| Device Manufacturer Date | 2004-06-01 |
| Date Added to Maude | 2006-11-15 |
| 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 | KIKOO TEJWANI |
| Manufacturer Street | 901 MARCON BLVD. |
| Manufacturer City | ALLENTOWN PA 18109 |
| Manufacturer Country | US |
| Manufacturer Postal | 18109 |
| Manufacturer Phone | 6102660500 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TYSHAK |
| Generic Name | BALLOON DILATION CATHETER |
| Product Code | MAD |
| Date Received | 2006-11-10 |
| Returned To Mfg | 2006-09-29 |
| Model Number | PDC017 |
| Catalog Number | 610534 |
| Lot Number | T2820 |
| ID Number | NA |
| Device Expiration Date | 2006-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 768341 |
| Manufacturer | B. BRAUN MEDICAL INC. |
| Manufacturer Address | * ALLENTOWN PA 18109 US |
| Baseline Brand Name | TYSHAK |
| Baseline Generic Name | BALLOON DILATION CATHETER |
| Baseline Model No | PDC017 |
| Baseline Catalog No | 610534 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-11-10 |