MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TRANSFORM COMPLIANT 4MM X 20MM - US; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Model Number	M003SRC04200
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an endovascular procedure at the distal anterior cerebral artery, the subject balloon failed to inflate.When the subject balloon was brought down to internal carotid artery, the subject balloon inflated slightly but failed to deflate.The subject balloon was then safely removed from the patient vasculature.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during an endovascular procedure at the distal anterior cerebral artery, the subject balloon failed to inflate.When the subject balloon was brought down to internal carotid artery, the subject balloon inflated slightly but failed to deflate.The subject balloon was then safely removed from the patient vasculature.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added, h3 device evaluated by mfg ¿updated, h3 summary attached - updated, d4 expiration date - added, d9 product available to stryker ¿ updated, d9 returned to manufacturer on ¿updated.Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned and the lot number was confirmed with the packaging.During visual/ microscopic inspection, it was noted that the device was returned with a possible synchro guidewire inserted in it.An rhv (rotating hemostatic valve), hemostasis valve and a torquer device were attached.No kinks or anomalies were noted on the catheter shaft.There was blood noted in the balloon and the distal catheter shaft (micromachined tube surface).During functional inspection, the balloon was inflated with the returned, connected media.No issues were noted on inflation.The device was attempted to deflate but failed.The guidewire could not be removed to inspect the transform.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 not confirmed based on analysis.The device failed to meet specification when received for complaint investigation based on the analyzed anomaly noted to the device.Additional information provided by the customer indicated that there was no damage noted to the packaging prior to the preparation of the device, 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, continuous flush was set up and maintained throughout the clinical procedure.The balloon was successfully inflated during preparation.The patients anatomy was significantly tortuous.Multiple inflation/deflation attempts were made.The device was returned for analysis and blood was noted on the distal catheter shaft and in the balloon.While the reported defects of balloon failed to inflate and balloon difficult to inflate was not confirmed during analysis of the returned device, it is most likely that procedural factors such as significant tortuosity as seen in the patient anatomy was encountered during the attempt to inflate the balloon during the procedure which would have contributed to the reported event.The reported event of balloon difficult/unable to deflate during use was confirmed during the analysis of the returned device.An assignable cause of 'procedural factors' will be assigned to the reported defects of balloon failed to inflate, balloon difficult to inflate and balloon difficult/unable to deflate during use and to the as analyzed event of balloon difficult/unable to deflate during use 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 COMPLIANT 4MM X 20MM - 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: 14764617
• Report Number: 3008881809-2022-00307
• Device Sequence Number: 14984452
• Product Code: MJN
• UDI-Device Identifier: 07613327004458
• UDI-Public: 07613327004458
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 09/12/2022

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: 04/11/2023
• Device Model Number: M003SRC04200
• Device Catalogue Number: M003SRC04200
• Device Lot Number: 22861217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2022
• Supplement Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2021
• 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