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

Catalog Number M003SRC05150

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/30/2017

Event Type  malfunction  

Manufacturer Narrative

The subject device is not available.

Event Description

During inflation of the occlusion balloon catheter on the intended area of treatment, it could not be inflated.The physician removed the occlusion balloon catheter from the patient's body.It was reported that upon attempt to inflate the occlusion balloon outside the patient's body, the physician confirmed balloon rupture.No patient consequences were reported due to this event.

Manufacturer Narrative

The device history record review confirms 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.Information available indicated that the device was confirmed to be in good condition prior to use.Based on the information currently available, the exact cause for the reported event cannot be determined.

Event Description

During inflation of the occlusion balloon catheter on the intended area of treatment, it could not be inflated.The physician removed the occlusion balloon catheter from the patient¿s body.It was reported that upon attempt to inflate the occlusion balloon outside the patient¿s body, the physician confirmed balloon rupture.No patient consequences were reported due to this event.

• Brand Name: TRANSFORM COMPLIANT 5MM X 15MM
• 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: 6709526
• MDR Text Key: 79894611
• Report Number: 3008881809-2017-00205
• 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: 09/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: M003SRC05150
• Device Lot Number: 18934285
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2016
• 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