MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT; CATHETER, PERCUTANEOUS

Catalog Number UNK_NEU

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

Patient Problem Fistula (1862)

Event Date 06/06/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during study procedure, the subject device distal access catheter along with other device (balloon guide catheter) were used to remove a clot from the left m1 middle cerebral artery (mca) femoral artery.The patient developed caroticocavernous fistula.However, the physician did not administer any treatment in response to the event and the event was resolved without any clinical consequences to the patient.It¿s indicated that the relationship of the event to the subject device and index procedure.No further information provided.

Manufacturer Narrative

Although the lot number was not provided, the automated manufacturing execution system (mes) has 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 reported 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 reported event.Additional information provided by the customer indicated that the subject catheter was confirmed to be in good condition post unpacking and preparation and it was prepared as per dfu.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned to the as reported.

Event Description

It was reported that during study procedure, the subject device distal access catheter along with other device (balloon guide catheter) were used to remove a clot from the left m1 middle cerebral artery (mca) femoral artery.The patient developed caroticocavernous fistula.However, the physician did not administer any treatment in response to the event and the event was resolved without any clinical consequences to the patient.It¿s indicated that the relationship of the event to the subject device and index procedure.No further information provided.Updated additional information: additional information received on 22-july-2020 stated that the subject device distal access catheter was used to access on the right femoral artery and the cause of the caroticocavernous fistula was a tear in the carotid artery by the catalyst (is being pulled up when the thrombectomy is performed).

• Brand Name: UNKNOWN_NEUROVASCULAR_PRODUCT
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 10274062
• MDR Text Key: 198845260
• Report Number: 3008881809-2020-00206
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K183463
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• 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: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLOWGATE2 BALLOON GUIDE CATHETER (STRYKER)
• Patient Outcome(s): Other
• Patient Age: 84 YR