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

Model Number	M003SSC07070
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) 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 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.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.Additional information provided by the customer indicated no damage was noted to the packaging prior to opening the packaging, the device was confirmed to be in good condition during preparation/prior to use on the patient, the device was prepared for use as per the directions for use, flush was given when the transform was taken out from the dispenser hoop, the entire system was flushed with a saline-contrast mixture, continuous flush was set up and maintained throughout the clinical procedure, the patient¿s anatomy was normal.There was no resistance when the gw was inserted.The gw was inserted, the entire system was flushed, and saline-contrast mixture confirmed it was flowed, it is unknown if friction or resistance was felt at the hub of the guiding catheter, a 1cc syringe was used to inflate the balloon in your body, contrast agent was diluted at 100%.The size of the concomitant device used was a gw: 0.014¿.There were no abnormalities such as air, leaks, or poor expansion when the balloon was expanded outside the body prior to the procedure.The location of the defect was the balloon.The reported event was that the balloon burst/ruptured.The damaged device was removed from the patient¿s anatomy by retraction, no snare was used.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 burst/ruptured during use¿ and ¿balloon failed to inflate¿.
Event or Problem Description
It was reported that during a neurovascular procedure, the subject balloon did not inflate when it was used to adjust a flow diverter against the walls of the vessel.Upon removal from the patient's anatomy for a visual inspection, the balloon was found burst/ruptured.The subject balloon was replaced and the procedure was completed successfully with no clinical consequences to the patient.

• 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: 16449310
• Report Number: 3008881809-2023-00090
• Device Sequence Number: 14920783
• Product Code: MJN
• UDI-Device Identifier: 07613327004700
• UDI-Public: 07613327004700
• 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
• Report Date (Section B): 02/27/2023

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: 09/19/2024
• Device Model Number: M003SSC07070
• Device Catalogue Number: M003SSC07070
• Device Lot Number: 23911484
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2022
• 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 0.014¿ (UNKNOWN MANUFACTURER); SURPASS STREAMLINE FLOW DIVERTER (STRYKER)
• Patient Sex: Female