MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-19 for BROCKENBROUGH? NEEDLE EP003994S manufactured by Medtronic Mexico.
[188900902]
Product event summary: the transseptal needle, ep003994s with lot number 208171403, was returned and analyzed. An image showed evidence of skiving. It is plausible that skiving occurred as there is a compatibility issue with the needle and a competitor sheath. The cause of the issue was not established. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188900923]
It was reported that during preparation of the sheath and the needle outside the patient, the user noticed that plastic material was scratched from the inside of the sheath by the needle (with dilator inserted). No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612164-2020-01238 |
| MDR Report Key | 9857940 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2014-07-17 |
| Date Mfgr Received | 2014-08-11 |
| Device Manufacturer Date | 2014-03-25 |
| Date Added to Maude | 2020-03-19 |
| 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 | 3 |
| Manufacturer Contact | PAULA BIXBY |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635055378 |
| Manufacturer G1 | MEDTRONIC MEXICO |
| Manufacturer Street | AV. PASEO DEL CUCAPAH #10510 |
| Manufacturer City | TIJUANA,BC 22570 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22570 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BROCKENBROUGH? NEEDLE |
| Generic Name | TROCAR |
| Product Code | DRC |
| Date Received | 2020-03-19 |
| Returned To Mfg | 2014-08-21 |
| Model Number | EP003994S |
| Catalog Number | EP003994S |
| Lot Number | 208171403 |
| Device Expiration Date | 2016-03-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC MEXICO |
| Manufacturer Address | AV. PASEO DEL CUCAPAH #10510 TIJUANA,BC 22570 MX 22570 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-19 |