MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TRANSFORM COMPLIANT 5MM X 10MM; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Catalog Number	M003SRC05100
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the subject device balloon was ruptured during the procedure.There was no clinical consequence to the patient as a result of this event.
Additional Manufacturer Narrative
Expiration date - added.Manufacturing date - added.Device evaluated by mfg ¿ updated to yes.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Analysis revealed that the balloon catheter was unable to be flushed as it was occluded with solidified contrast media.Following the functional test, leaks were observed from the balloon.It is probable that the device was damaged during the clinical procedure contributing to the reported event.An assignable cause of procedural factor 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 directions for use (dfu) but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
It was reported that the subject device balloon was ruptured during the procedure.There was no clinical consequence to the patient as a result of this event.

• Brand Name: TRANSFORM COMPLIANT 5MM X 10MM
• Common Device Name: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7571824
• Report Number: 3008881809-2018-00254
• Device Sequence Number: 2063291
• Product Code: MJN
• UDI-Device Identifier: 07613327004687
• UDI-Public: 07613327004687
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• 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): 07/30/2018

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: 08/31/2019
• Device Catalogue Number: M003SRC05100
• Device Lot Number: 19939096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Initial Date Received by Manufacturer: 05/11/2018
• Supplement Date Received by Manufacturer: 07/11/2018
• Initial Report FDA Received Date: 06/05/2018
• Supplement Report FDA Received Date: 07/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SYNCHRO GUIDEWIRE (STRYKER)