MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-01 for DYNJ45005 manufactured by Martech Medical Products Inc.
[115777158]
It was reported that during a trans-thoracic procedure (direct stick to the aorta), the st. Jude/abbott. 035/150 3mm j wire (ref# (b)(4)) got caught in the 18 gauge x 2. 75 inches introducer needle, a component from the cath lab pack. Reportedly, after the guidewire was noted stuck in the needle, the physician successfully pulled the needle and guidewire out of the patient. There was no serious injury or follow-up care reported related to the event. The patient did not require additional sedation as a result of this incident. There was no impact to the patient, the procedure, or a staff member. The patient is reportedly doing well at this time. Due to the reported incident and in an abundance of caution, this medwatch is being filed. The sample was not available to be returned for evaluation. A third party notification has been completed with the manufacturer of the introducer needle involved with this event. No additional information is available. If additional information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[115777159]
It was reported that during a trans-thoracic procedure (direct stick to the aorta), the guidewire got caught in the introducer needle, a component from the cath lab pack.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2018-00041 |
| MDR Report Key | 7739137 |
| Date Received | 2018-08-01 |
| Date of Report | 2018-08-01 |
| Date of Event | 2018-07-25 |
| Date Mfgr Received | 2018-07-25 |
| Date Added to Maude | 2018-08-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BERMON PUNZALAN |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 2249311514 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | INTRODUCER NEEDLE FROM CATH LAB PACK |
| Product Code | OES |
| Date Received | 2018-08-01 |
| Catalog Number | DYNJ45005 |
| Lot Number | 18DK1917 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MARTECH MEDICAL PRODUCTS INC |
| Manufacturer Address | 1500 DELP DR HARLEYSVILLE PA 19438 US 19438 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-01 |