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	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during post percutaneous transluminal angioplasty (pta) procedure, the operator delivered the subject balloon catheter and attempted to inflate the subject device.However, the subject balloon was found to be leaking.Upon withdrawal, it was discovered that the subject balloon catheter was also fractured.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.Visual and functional inspections were not conducted due to the device 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.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 average tortuous.The entire system was flushed with a saline-contrast mixture.The size of the concomitantly used guidewire was 0.014¿.There was no resistance when the guidewire was inserted.After the guidewire was inserted, the entire system was flushed, and saline-contrast mixture confirmed it was flowed.There was no resistance encountered during inserting the balloon through catheter.The contrast agent was diluted at 80%.There was no friction and no resistance at the hub of the guiding catheter.A 1cc syringe was used to inflate the balloon in the body.There were no abnormalities such as air, leaks, or poor expansion when the balloon was expanded outside the body.The correct inflation medium was used to inflate the balloon as per the dfu.The device was not inflated over nominal pressure and no excessive pressure was used.The balloon was able to be successfully inflated/deflated during preparation.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 events ¿balloon leaked during use¿ and ¿balloon catheter broken/fractured during use¿.

• 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: 20612286
• Report Number: 3008881809-2024-00529
• Device Sequence Number: 15306355
• Product Code: MJN
• UDI-Device Identifier: 07613327004700
• UDI-Public: (01)07613327004700(17)260421(10)24912355
• 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): 11/05/2024

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: 04/21/2026
• Device Catalogue Number: M003SSC07070
• Device Lot Number: 24912355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2024
• 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: PIPELINE STENT SYSTEM (NON-STRYKER).
• Patient Sex: Unknown