MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TRANSFORM SUPER COMPLIANT 4MM X 10MM- CE; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Catalog Number M003ESC04100

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/19/2022

Event Type  malfunction  

Manufacturer Narrative

Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.On visual/microscopic inspection it was noted that the balloon had been sheared off and the ldpe/lldpe tubing jagged as.Dried crystalized procedural fluid was also present.A functional inspection could not be performed due to damage to the device.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 anomaly noted to the device.Additional information provided by the customer indicated that there were no anomalies noted to the device prior to use, continuous flush was maintained and the lumen of the catheter was flushed through with heparinized saline.The balloon catheter system was used as per dfu and the balloon inflated/deflated during prep.The correct amount of inflation media was used to inflate the balloon, 50% contrast - 50% saline was used during preparation and procedure.There was no leakage noted during preparation and the material was prepared according to the manufacturer's instructions for use.The balloon was inside the patient when inflation issue occurred.The tip of the guidewire was approximately 2-3cm to the distal part of the balloon in relation to the tip of the balloon catheter.The patient¿s anatomy was a little tortuous.The anatomy location was the right internal carotid, superior pituitary artery when the balloon did not inflate.Product analysis found the balloon had been sheared off and the ldpe/lldpe tubing was jagged which indicates the device encountered a significant manipulation during preparation.The reported event was confirmed during product analysis.The as reported ¿balloon failed to inflate¿ and as analyzed ¿balloon detached/separated¿ and ¿balloon 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.

Event Description

The subject device was returned for analysis and the device investigation revealed that subject balloon was detached/separated.The subject balloon was replaced and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TRANSFORM SUPER COMPLIANT 4MM X 10MM- CE
• Type of Device: 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: 16031346
• MDR Text Key: 308234798
• Report Number: 3008881809-2022-00644
• Device Sequence Number: 1
• Product Code: MNJ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K122576
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2023
• Device Catalogue Number: M003ESC04100
• Device Lot Number: 23308973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female