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

Catalog Number M003ERC04100

Device Problem Hole In Material (1293)

Patient Problem No Patient Involvement (2645)

Event Date 02/11/2018

Event Type  malfunction  

Manufacturer Narrative

The subject device is not available.

Event Description

During the preparation, it was reported that the balloon could not be inflated.Therefore, the physician thought it was due to a pin hole in the balloon.The procedure was completed with another device.No clinical consequences reported to the patient.

Event Description

During the preparation, it was reported that the balloon could not be inflated.Therefore, the physician thought it was due to a pin hole in the balloon.The procedure was completed with another device.No clinical consequences reported to the patient.

Manufacturer Narrative

The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.As per the additional information, the device was confirmed to be in good condition when unpacked and the device was prepared as per the dfu (direction for use).Based on the information currently available the exact cause for the reported balloon failed to inflate and balloon has hole/perforation cannot be determined.

• Brand Name: TRANSFORM COMPLIANT 4MM X 10MM
• Type of Device: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7315297
• MDR Text Key: 101565634
• Report Number: 3008881809-2018-00096
• Device Sequence Number: 1
• Product Code: MJN
• Combination Product (y/n): N
• PMA/PMN Number: K122576
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: M003ERC04100
• Device Lot Number: 20069314
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRANSEND GUIDEWIRE (STRYKER)
• Patient Age: 16 YR