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

Model Number	90073
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a left internal carotid artery (ica) occlusion case when the balloon (subject device) was delivered to the treatment site and inflated, contrast agent was found leaking from it.The device was replaced and the procedure was completed successfully with no clinical consequences to the patient.
Additional Manufacturer Narrative
H3 summary attached - updated.H3 device evaluated by mfg ¿updated.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 device was returned within its dispenser hoop and the lot number was not confirmed as the device was not returned with its packaging.During visual inspection, the subject balloon was noted to be ruptured and with blood within it and within its hub.During functional testing, an attempt was made to inflate the balloon; however, it was unable to inflate due to procedural fluids within the balloon and catheter.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 event was confirmed based on the damage noted to the device.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that they placed the balloon and then prepared to use an intermediate catheter to do aspiration, but when inflating the balloon, the balloon was found leaked.As per the available information, the patients anatomy was moderately tortuous, a 1ml syringe was used to inflate the balloon, the correct inflation medium was used to inflate the balloon as per the dfu, the device was not inflated over nominal pressure or excessive pressure used, the balloon was able to be successfully inflated during preparation and there was no leakage noted during preparation.The device was returned for analysis and it was confirmed that the balloon had burst/ruptured.It is probable that the device was damaged during use causing the reported event.An assignable cause of procedural factors will be assigned to both as reported event of 'balloon leaked during use' as well as to as analyzed event of '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 left internal carotid artery (ica) occlusion case when the balloon (subject device) was delivered to the treatment site and inflated, contrast agent was found leaking from it.The device was replaced and the procedure was completed successfully with no clinical consequences to the patient.

• Brand Name: MERCI BGC 8F 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
• 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: 15868757
• Report Number: 3012931345-2022-00211
• Device Sequence Number: 17445552
• Product Code: DQY
• UDI-Device Identifier: 00815742000733
• UDI-Public: 00815742000733
• 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): 01/10/2023

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: 03/30/2023
• Device Model Number: 90073
• Device Catalogue Number: 90073
• Device Lot Number: 0000061482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/01/2022
• Supplement Date Received by Manufacturer: 12/17/2022
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AXS CATALYST 5 CATHETER (STRYKER); PINNACLE 8F SHEATH (TERUMO); XT-27 MICROCATHETER (STRYKER)
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 64 KG
• Patient Race: Asian