MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY MERCI BGC 8F X 95CM; CATHETER, PERCUTANEOUS

Model Number 90073

Device Problem Deflation Problem (1149)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/07/2022

Event Type  malfunction  

Manufacturer Narrative

The device is not available to the manufacturer.

Event Description

It was reported that during a thrombectomy procedure, the balloon (subject device) was inflated in the ica (internal carotid artery) but once the clot retrieval was completed the balloon would not deflate.The physician made several unsuccessful attempts to deflate and burst the balloon before pulling the subject balloon guide catheter out of the patient while the balloon was inflated resulting in surgical delay.No clinical consequences were reported to the patient due to this event.

Event Description

It was reported that during a thrombectomy procedure, the balloon (subject device) was inflated in the ica (internal carotid artery) but once the clot retrieval was completed the balloon would not deflate.The physician made several unsuccessful attempts to deflate and burst the balloon before pulling the subject balloon guide catheter out of the patient while the balloon was inflated resulting in surgical delay.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

H4 manufacturing date ¿ added.D4 expiration date - added.Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.The subject device is not available; therefore, functional testing as well as visual testing cannot 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.It was reported that the doctor wanted to deflate the balloon prior to removing it from the anatomy, by using a 20 ml syringe ¿ unfortunately, the balloon did not deflate.The doctor tried several attempts, also using a 1 ml syringe, and a 60 ml syringe- but the balloon did not deflate.Having no choice, the doctor tried to add more inflation media to blow up the balloon.Still, the balloon did not deflate.The available information also states that the balloon was prepared as needed and was inflated and deflated with no problems during the preparation phase.It is possible that the balloon guide catheter may have sustained some damage during advancement through the patients anatomy causing the reported difficulty to deflate the balloon, however this cannot be definitively determined.As the device was not returned and a review of all available information fails to indicate an assignable cause for the reported event, an assignable cause of undeterminable will be assigned to this complaint.

• Brand Name: MERCI BGC 8F X 95CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer (Section G): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 15568616
• MDR Text Key: 306565410
• Report Number: 3012931345-2022-00180
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00815742000733
• UDI-Public: 00815742000733
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K112404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/09/2022

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 Expiration Date: 12/08/2023
• Device Model Number: 90073
• Device Catalogue Number: 90073
• Device Lot Number: 0000095842
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 10/10/2022
• Supplement Dates Manufacturer Received: 11/16/2022
• Supplement Dates FDA Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1