MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TRANSFORM SUPER COMPLIANT 4MM X 7MM; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Catalog Number M003ESC04070

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/21/2017

Event Type  malfunction  

Manufacturer Narrative

The subject device is not available.

Event Description

It was reported that during procedure the subject balloon was not inflated and the pin hole was confirmed at the balloon.The procedure was continued with same new device and the patient was recovered.There were no reported clinical adverse consequences to the patient due to the event.

Manufacturer Narrative

Expiration date: added.Manufacturing date: added.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.Based on the information available the exact cause for the reported event cannot be determined.

Event Description

It was reported that during procedure the subject balloon was not inflated and the pin hole was confirmed at the balloon.The procedure was continued with same new device and the patient was recovered.There were no reported clinical adverse consequences to the patient due to the event.

• Brand Name: TRANSFORM SUPER COMPLIANT 4MM X 7MM
• Type of Device: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 7192475
• MDR Text Key: 97503061
• Report Number: 3008881809-2018-00043
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: M003ESC04070
• Device Lot Number: 19834738
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2016
• 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 Age: 51 YR