MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY MERCI BGC 9F X 95CM; CATHETER, PERCUTANEOUS

Model Number	90074
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not yet received for evaluation.
Event or Problem Description
It was reported that during a middle cerebral artery acute thrombectomy case, the contrast agent used to dilate the balloon (subject device) leaked in the patient.The subject balloon was removed from the patient anatomy and dilated.It was found to have ruptured.The physician replaced the subject device and completed the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
The device was returned for evaluation with no packaging.The lot number could not be confirmed because the packaging was not returned with the device.During visual inspection, the balloon material was noted to be ruptured.During the functional inspection the balloon was not attempted to be inflated due to the damage noted.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 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.The reported complaint was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation.As per the available information, the balloon was able to be successfully inflated during preparation and there was no leakage noted during preparation.The device was returned and the device was noted to be burst ruptured, confirming the reported event.It is probable that it was damaged during advancement to the target vessel or during inflation within the patient.An assignable cause of procedural factors will be assigned to the reported event of the balloon leaked during use and burst/ruptured during use and the analyzed balloon burst/ruptured during use, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
It was reported that during a middle cerebral artery acute thrombectomy case, the contrast agent used to dilate the balloon (subject device) leaked in the patient.The subject balloon was removed from the patient anatomy and dilated.It was found to have ruptured.The physician replaced the subject device and completed the procedure without clinical consequences to the patient.

• Brand Name: MERCI BGC 9F X 95CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• MDR Report Key: 11698196
• Report Number: 3012931345-2021-00067
• Device Sequence Number: 3721704
• Product Code: DQY
• UDI-Device Identifier: 00815742000740
• UDI-Public: 00815742000740
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K112404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/29/2022
• Device Model Number: 90074
• Device Catalogue Number: 90074
• Device Lot Number: 0000040137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 68