MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TRANSFORM SUPER COMPLIANT 7MM X 7MM - US; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Catalog Number	M003SSC07070
Medical Device Problem Codes	Material Puncture/Hole (1504); No Visual Prompts/Feedback (4021)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when inflated the subject balloon inside the body, it could not be seen under fluoroscopy, and when inflated outside the body, it was confirmed that the subject balloon was torn.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that when inflated the subject balloon inside the body, it could not be seen under fluoroscopy, and when inflated outside the body, it was confirmed that the subject balloon was torn.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added d4 expiration date - added due to the automated mes (manufacturing execution system) system there are 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.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Additional information provided by the customer did not indicate any issues noted during unpacking or set up of the device, and the device was prepared as per dfu instructions.There was no indication of a user related issue.The anatomy was reported to be severely tortuous which may have contributed to the reported issue.The entire system was flushed with a 50% saline-contrast mixture.The catheter was flushed to facilitate guidewire insertion.There was no resistance when the 0.014¿ guidewire was inserted.There was no resistance encountered during the guidewire insertion or during inserting the balloon through catheter.There was no friction and no resistance at the hub of the guiding catheter.The correct inflation medium was used to inflate the balloon as per the dfu (device directions for use).A 1cc syringe was used to inflate the balloon in the body.The device was not inflated over nominal pressure or excessive pressure used.The balloon was able to be successfully inflated/deflated during preparation.There were abnormalities such as air, leaks, or poor expansion when the balloon was expanded outside the body at the preparation, but there were when it was retrieved from the body.These abnormalities were neither leaks nor the introduction of air.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 for the reported issue ¿balloon has hole/perforation during use¿ and ¿device or device component not visible under fluoroscopy¿.

• Brand Name: TRANSFORM SUPER COMPLIANT 7MM X 7MM - US
• Common Device Name: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 20591553
• Report Number: 3008881809-2024-00517
• Device Sequence Number: 20465223
• Product Code: MJN
• UDI-Device Identifier: 07613327004700
• UDI-Public: (01)07613327004700(17)260602(10)24984755
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122576
• 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): 11/26/2024

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: 06/02/2026
• Device Catalogue Number: M003SSC07070
• Device Lot Number: 24984755
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2024
• 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: GUIDEWIRE (UNKNOWN).; MICROCATHETER (UNKNOWN).
• Patient Sex: Unknown