MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TRANSFORM COMPLIANT 5MM X 15MM - US; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Catalog Number	M003SRC05150
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The balloon (subject device) was returned for analysis and it was discovered that there was a tear/hole/perforation noted on the balloon (subject device).The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, there were no visual anomalies noted to the device.During a functional inspection, a demonstration 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 hole/perforation.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 specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated there was no damage noted to the packaging prior to preparation of the device, the balloon catheter system was used as per dfu, no other anomalies were noted to the device after removal from the packaging or prior to preparation , continuous flush was maintained.50% contrast was used during procedure.It is most likely that the device may have been unintentionally damaged during preparation as inflation difficulty was noted during the preparation, but was continued to be used during the procedure.Additional information states the balloon continued to lose inflation during the preparation stages."was the balloon able to be successfully inflated/deflated during preparation? yes, but continued to lose inflation".During analysis, the balloon catheter was inspected and a tear/hole/perforation was noted on the balloon.An assignable cause of procedural factors will be assigned to the as reported and as analyzed defect 'balloon difficult to inflate' along with the additional as analyzed defect 'balloon has hole/perforation during use' since these issues is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.

• Brand Name: TRANSFORM COMPLIANT 5MM X 15MM - 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: 19035917
• Report Number: 3008881809-2024-00145
• Device Sequence Number: 7042192
• Product Code: MJN
• UDI-Device Identifier: 07613327004472
• UDI-Public: 07613327004472
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 04/03/2024

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: 03/07/2024
• Device Catalogue Number: M003SRC05150
• Device Lot Number: 23528719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2022
• 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: SYNCHRO 2 GUIDEWIRE (STRYKER).
• Patient Sex: Unknown