MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF MERCI BGC 9F X 95CM; CATHETER, PERCUTANEOUS

Catalog Number	90074
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during mechanical thrombectomy, inflation of the subject balloon with immediate leakage of product observed on fluoroscopy.The procedure was completed successfully with no clinical consequences to the patient.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added, h3 device evaluated by mfg ¿updated, d4 expiration date - added, d4 gtin # - added, d9 product available to stryker ¿ updated, d9 returned to manufacturer on ¿updated.Based on the results of the device history record (dhr) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.During the visual inspection, there was no damage/deformation noted to the subject balloon catheter shaft.There was a wrinkle present near the proximal end of the subject balloon.During the functional inspection, an attempt was made to inflate the subject balloon.The subject balloon partially inflated.However it was not possible to fully inflate the subject balloon as there was a leak present.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 event involved 'standard preparation of the subject balloon.No prior inflation.During the combined technique, inflation of the subject balloon with immediate leakage of product observed on fluoroscopy.Balloon not functional'.Note: the dfu instructs that, prior to use, each merci device is fully aspirated.If there was a leak in the balloon, it would be noted as a continuous flow of bubbles at this preparation step.In addition, steps 8 and 9 of the dfu (nv00021446) state: 8.Inflate balloon with maximum recommended inflation volume.Turn stopcock off towards balloon hub.9.Inspect balloon for leakage.Keep balloon inflated until air bubbles diffuse from balloon.During analysis, the subject balloon catheter shaft was noted to be undamaged.The distal tip of the subject balloon catheter was undamaged.There was a wrinkle present near the proximal end of the subject balloon.An attempt was made to inflate the subject balloon.While the subject balloon could partially inflate, a leak was noted.In the case of this complaint, it is most likely that the issue occurred due to an unknown procedural factor and/or anatomical factors during the procedure.This, however, cannot be conclusively determined.An assignable cause of procedural factors will be assigned to the as reported and analyzed code, 'balloon leaked during use'.This issue is associated with a product that meets stryker design and manufacture specifications, but performance was limited due to procedural and/or anatomical factors during use.
Event or Problem Description
It was reported that during mechanical thrombectomy, inflation of the subject balloon with immediate leakage of product observed on fluoroscopy.The procedure was completed successfully with no clinical consequences to the patient.

• Brand Name: MERCI BGC 9F X 95CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• Manufacturer (Section G): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 22894575
• Report Number: 3008853977-2025-00019
• Device Sequence Number: 5828297
• Product Code: DQY
• UDI-Device Identifier: 00815742000740
• UDI-Public: (01)00815742000740(17)270114(10)0000778451
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2025

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 Catalogue Number: 90074
• Device Lot Number: 0000778451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/08/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2025
• 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
• Patient Sex: Unknown