MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TRANSFORM SUPER COMPLIANT 4MM X 7MM - US; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Catalog Number	M003SSC04070
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The subject device was returned for analysis and the device investigation revealed that the balloon had hole/perforation during use.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
Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection the balloon was examined microscopically and the distal catheter shaft was noted to be damaged at approximately 127.5 - 130cm from strain relief.During functional inspection a demonstration 0.014 guidewire was advanced to the distal tip without resistance.An attempt was made to inflate the balloon, and a leak was discovered due to the split/tear/puncture.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 specification when received for complaint investigation based on the analyzed anomalies noted to the device.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.Flush was given when the device was taken out from the dispenser hoop and there was no resistance when taken out of dispenser hoop/protective tube.There was no indication of a user related issue.The entire system was flushed with a saline-contrast mixture.The size of concomitantly used guidewire (gw) was 0.014.After the gw was inserted, the entire system was flushed, and saline-contrast mixture was confirmed it was flowed.The defect was not identified at the time of preparation.The device was inside the patent when the leak was identified.The anatomy was reported to be average tortuous.Analysis of the returned device found the balloon was examined microscopically and the distal catheter shaft was noted to be damaged at approximately 127.5 - 130cm from strain relief.An attempt was made to inflate the balloon, and a leak was discovered due to the split/tear/puncture of the balloon itself.The good faith effort attempts have been completed in our effort to obtain answers to follow up questions.However, as of today, no additional information was provided; therefore, the investigation will proceed with the information currently available.Should information became available that could potentially impact the current assessment decision of this record and/or the root cause of the investigation, the record will be reopened to incorporate and assess the information accordingly.The as reported event 'balloon difficult to inflate' and as analysed events 'balloon failed to inflate', 'balloon has hole/perforation during use' and 'balloon catheter shaft damaged' will be assigned procedural factors as these defects appear to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural or anatomical factors during use.

• Brand Name: TRANSFORM SUPER COMPLIANT 4MM 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: 21922031
• Report Number: 3008881809-2025-00232
• Device Sequence Number: 9030897
• Product Code: MJN
• UDI-Device Identifier: 07613327004694
• UDI-Public: (01)07613327004694(17)260820(10)25120107
• 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): 04/28/2025

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 Expiration Date: 08/20/2026
• Device Catalogue Number: M003SSC04070
• Device Lot Number: 25120107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2024
• 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
• Patient Sex: Unknown