MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2011-06-03 for TAUT INTRADUCERS 8RF PI-104 manufactured by Teleflex Medical.
[17194747]
The event is reported as: alleged issue: tip of sheath broke off inside the patient while performing the procedure. All the pieces were retrieved, including the tip, and another device was used with no further issues. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[17314756]
Sample has been received by manufacturer but investigation is incomplete at time of this report. A follow up report will be sent when investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003898360-2011-00261 |
| MDR Report Key | 2158598 |
| Report Source | 05,06,07 |
| Date Received | 2011-06-03 |
| Date of Report | 2011-05-23 |
| Date of Event | 2011-05-23 |
| Date Mfgr Received | 2011-05-23 |
| Device Manufacturer Date | 2010-10-01 |
| Date Added to Maude | 2011-11-18 |
| 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 | JASMINE BROWN |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9193614124 |
| Manufacturer Street | PROLONGACION MISION EUSEBIO KINO #1316, RANCHO EL DESCANSO |
| Manufacturer City | TECATE, B.C. C.P.214 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | C.P. 2147 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TAUT INTRADUCERS 8RF |
| Generic Name | TAUT INTRADUCER |
| Product Code | GBW |
| Date Received | 2011-06-03 |
| Returned To Mfg | 2011-05-31 |
| Catalog Number | PI-104 |
| Lot Number | 01K1000038 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | TECATE MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-03 |