MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT; MICROCATHETER

Catalog Number UNK_NEU

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

Patient Problems Embolus (1830); Vascular Dissection (3160)

Event Date 05/16/2020

Event Type  Injury  

Manufacturer Narrative

This is 3rd of four reports.The subject device is unavailable to manufacturer.

Event Description

It was reported that during study procedure, the embolization to new territory (ent) occurred, therefore; a thrombectomy was performed in response to the patient¿s embolization to new territory.According to the site, the reported event was related to the index stroke, procedure and the subject device (microcathter).The outcome was resolved, and no adverse consequence reported.

Manufacturer Narrative

Although the dhr could not be reviewed because the lot number remains unknown, there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The analysed event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as analysed event.As a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labeling and/or risk documentation files, an assignable cause of anticipated procedural complication will be assigned to this complaint.This is 3rd of four reports.

Event Description

It was reported that during study procedure, the embolization to new territory (ent) occurred, therefore; a thrombectomy was performed in response to the patient¿s embolization to new territory.According to the site, the reported event was related to the index stroke, procedure and the subject device (microcathter).The outcome was resolved, and no adverse consequence reported.Update additional information: received additional information on 22-july-2020 indicated that the carotid lesion was already occurred during procedure and was not related to the subject device.

• Brand Name: UNKNOWN_NEUROVASCULAR_PRODUCT
• Type of Device: MICROCATHETER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 10094712
• MDR Text Key: 192378969
• Report Number: 3008881809-2020-00158
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K113778
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NEU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/19/2020
• Initial Date FDA Received: 05/27/2020
• Supplement Dates Manufacturer Received: 08/14/2020
• Supplement Dates FDA Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLOWGATE 2 BALLOON GUIDE CATHETER (STRYKER); SYNCHRO 2 GUIDEWIRE (STRYKER); TREVO XP PROVUE RETRIEVER 6X25 (STRYKER); FLOWGATE 2 BALLOON GUIDE CATHETER (STRYKER); SYNCHRO 2 GUIDEWIRE (STRYKER); TREVO XP PROVUE RETRIEVER 6X25 (STRYKER)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 45 YR