MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-29 for NEUROSCOUT 14, STD 601314 manufactured by Codman And Shurtleff, Inc.
[140636621]
Product complaint # (b)(4). Additional information received on 14-mar-2019 indicated that the neuroscout guidewire and prowler select microcatheter were removed from the patient and replaced, resulting in a loss of cerebral target position. Concomitant med products due to character limitation: envoy da xb, 6f, 105cm, mpd (67125805db/e11619) guiding catheter. Initial reporter contact information, including phone, fax, and e-mail address, was not reported. "distributor" was also selected as the report source since the distributor (neomex) notified the manufacturer of the event. The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed. Additional information will be submitted within 30 days of receipt. A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report. This is one of two products involved with the complaint and the associated manufacturer report numbers are 1226348-2019-00874 & 1226348-2019-00875.
Patient Sequence No: 1, Text Type: N, H10
[140636622]
As reported by a healthcare professional, during a coil embolization of a non-tortuous pericallosal artery aneurysm, the 6f envoy da guide catheter was positioned and the prowler select lpes (606s155fx/17680646) microcatheter and neuroscout 14 std (601314/hu8939) guidewire were introduced, but the guidewire became impeded in the body/shaft of the microcatheter near the site of the aneurysm and the physician was unable to remove the guidewire from the microcatheter. Maneuvers were made in an attempt to? Drop? The guidewire from inside of the microcatheter, but the physician ultimately decided to withdraw the guidewire and microcatheter from the guide catheter as a unit. Upon removal, the physician noticed that the guidewire was trapped inside of the microcatheter and the devices were? Fixed?. The guidewire and microcatheter were replaced, and the procedure was completed successfully with the same envoy guide catheter. No patient complications occurred as a result of the event. The length of time that the surgery was delayed due to the event was not reported; however, the delay was not considered clinically significant. The devices were stored, prepped, and flushed according to the instructions for use (ifu). The devices did not appear kinked or bend at any time. The devices will be returned for evaluation. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226348-2019-00875 |
| MDR Report Key | 8464256 |
| Date Received | 2019-03-29 |
| Date of Report | 2019-02-12 |
| Date of Event | 2019-02-09 |
| Date Mfgr Received | 2019-05-01 |
| Device Manufacturer Date | 2018-04-17 |
| Date Added to Maude | 2019-03-29 |
| 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 | MR. GABRIEL ALFAGEME |
| Manufacturer Street | 31 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9497898687 |
| Manufacturer G1 | CODMAN AND SHURTLEFF, INC |
| Manufacturer Street | 325 PARAMOUNT DR |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NEUROSCOUT 14, STD |
| Generic Name | WIRE, GUIDE, CATHETER, NEUROVASCULAR |
| Product Code | MOF |
| Date Received | 2019-03-29 |
| Returned To Mfg | 2019-03-13 |
| Catalog Number | 601314 |
| Lot Number | HU8939 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN AND SHURTLEFF, INC |
| Manufacturer Address | 325 PARAMOUNT DR RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-29 |