MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY UNKNOWN_NEUROVASCULAR_PRODUCT; CATHETER, THROMBUS RETRIEVER

Catalog Number UNK_NEU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Embolus (1830)

Event Date 09/19/2019

Event Type  Injury  

Manufacturer Narrative

This is 1 of 2 reports.The subject device is unavailable to manufacturer.

Event Description

It was reported that during treatment of the occluded in m1 segment of the middle cerebral artery (mca), an emboli to new territory had occurred.No adverse event associated with the new embolization was reported.No further information is available.

Manufacturer Narrative

Additional information received from the site clarified that there was no complaint against the subject device.Furthermore, the site was confirmed that there was no new ent (embolization to new territory) and it was data error to report it.Based on this update, the event does not meet the criteria for a complaint.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the subject device.This is 1 of 2 reports.

Event Description

It was reported that during treatment of the occluded in m1 segment of the middle cerebral artery (mca), an emboli to new territory had occurred.No adverse event associated with the new embolization was reported.No further information is available.Update additional information: additional information received from the site clarified that there was no complaint against the subject device.Furthermore, the site was confirmed that there was no new ent (embolization to new territory) and it was data error to report it.There was no clinical consequences to the patient reported.

• Brand Name: UNKNOWN_NEUROVASCULAR_PRODUCT
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• MDR Report Key: 9205785
• MDR Text Key: 162821394
• Report Number: 3012931345-2019-00081
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• PMA/PMN Number: K132641
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NEU
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALLOON GUIDE CATHTER ( STRYKER)
• Patient Outcome(s): Other
• Patient Age: 93 YR