MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO 2/14 200 CM SOFT; WIRE, GUIDE, CATHETER

Catalog Number M00326010

Device Problem Flaked (1246)

Patient Problem No Patient Involvement (2645)

Event Date 01/30/2019

Event Type  malfunction  

Manufacturer Narrative

Device not returned.

Event Description

It was reported that strands/threads were noticed on the guidewire when removed from the packaging.There were no clinical consequences to the patient reported due to this event.No additional information was provided.

Manufacturer Narrative

Although the device history record (dhr) review could not be reviewed because the bath remained unknown, there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not returned for analysis; therefore, visual, dimensional and functional testing could not be performed.In case of this complaint, there are a number of potential causes for the reported issue, but because review and analysis of available information failed to identify a definitive cause, an assignable cause of undeterminable was assigned to the as reported issue guidewire ptfe coating peeling.

Event Description

It was reported that strands/threads were noticed on the guidewire when removed from the packaging.There were no clinical consequences to the patient reported due to this event.No additional information was provided.

• Brand Name: SYNCHRO 2/14 200 CM SOFT
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• MDR Report Key: 8371972
• MDR Text Key: 137261426
• Report Number: 3012931345-2019-00021
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 04546540688729
• UDI-Public: 04546540688729
• Combination Product (y/n): N
• PMA/PMN Number: K053268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M00326010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/31/2019
• Initial Date FDA Received: 02/26/2019
• Supplement Dates Manufacturer Received: 03/27/2019
• Supplement Dates FDA Received: 04/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1