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

Catalog Number	M003SSC07070
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that there was a hole in the balloon (subject device).There were no clinical consequences to the patient due to the reported event.
Event or Problem Description
It was reported that there was a hole in the balloon (subject device).There were no clinical consequences to the patient due to the reported event.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Inspection of the returned device was found to be kinked near the proximal end most likely due to handling of the device during use.Additionally, the balloon lumen was found to be blocked due to crystallized contrast used in the procedure.The balloon was visually inspected and a hole was noted near the distal tip.A function test was unable to be performed because the balloon lumen was blocked.Based on the information available and analysis of the returned device, an assignable cause of 'procedural factors¿ will be assigned to this investigation, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the device direction for use (dfu) but due to procedural and/or anatomical factors during use, the product performance was limited.

• Brand Name: TRANSFORM SUPER COMPLIANT 7MM X 7MM
• Common Device Name: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8625123
• Report Number: 3008881809-2019-00135
• Device Sequence Number: 2169138
• Product Code: MJN
• UDI-Device Identifier: 07613327004700
• UDI-Public: 07613327004700
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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): 08/06/2019

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: 03/04/2021
• Device Catalogue Number: M003SSC07070
• Device Lot Number: 21284834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 08/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1