MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-04 for MARKSMAN FA-55150-1030 manufactured by Micro Therapeutics, Inc. Dba Ev3.
[182741027]
The customer provided images of the marksman catheter for review. In the images provided, the distal end of the marksman catheter appears to be flattened and accordioned. In addition, there appears to be separation of the catheter body. The location or length of catheter separation could not be determined from the images provided. Based on the images provided, the report of "catheter kink/damage" was confirmed. However, since the device was not returned, we are unable to perform further root cause analysis and the exact cause of the reported event is unknown. All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture. No corrective action. Monitoring and trending this type of event. Linked with mdr: 2029214-2020-00194. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182741028]
Medtronic received report that the pipeline flex distal section did not open. Upon removal of the devices, the tip of the marksman catheter was noted to be damaged and kinked. This event occurred in the internal carotid artery (ica). The ica aneurysm was unruptured, and amorphous. The max diameter was 4. 5 mm and the neck was 4. 5 mm. The distal landing zone was 3. 5 mm and the proximal was 4. 5 mm. The vessel anatomy was moderate in tortuosity. The pipeline and the accessory devices were prepared as indicated in the instructions for use (ifu). No patient injury occurred. Post the intervention, the angiographic results were good. A new pipeline device was used to treat the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029214-2020-00195 |
| MDR Report Key | 9788596 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2019-07-19 |
| Date Added to Maude | 2020-03-04 |
| 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 | MGR. KATCHA TAYLOR |
| Manufacturer Street | 9775 TOLEDO WAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9496801345 |
| Manufacturer G1 | MICRO THERAPEUTICS, INC. DBA EV3 |
| Manufacturer Street | 9775 TOLEDO WAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MARKSMAN |
| Generic Name | CATHETER, CONTINUOUS FLUSH |
| Product Code | KRA |
| Date Received | 2020-03-04 |
| Model Number | FA-55150-1030 |
| Lot Number | 218109412 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICRO THERAPEUTICS, INC. DBA EV3 |
| Manufacturer Address | 9775 TOLEDO WAY IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-04 |