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Model Number FA-71375-30
Device Problem Flaked (1246)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/04/2016
Event Type  malfunction  
Manufacturer Narrative
As received, approximately 49. 0cm of the pipeline pushwire was extending out of the proximal end of the catheter hub. The pipeline was then dissected at multiple points to remove the pipeline delivery system. The tip coil was found to be stretched and pipeline braid was found to be contained within the capture coil. The pipeline braid was then released from the capture coil with no issues. The pipeline braid was found to be fully open with the distal and proximal ends having slight fraying. The proximal bumper was found to be loose on the pushwire and the pushwire was kinked. The microcatheter was also observed accordioned. The coating of the entire pushwire length was examined under the video inspection system (30x magnification) for coating integrity. Coating damage was observed at approximately 53. 0cm to 57. 0cm, 38. 0cm to 44. 0cm, and 7. 0cm to 30. 0cm from the proximal end. No coating flakes were found within the microcatheter hub. Based on the analysis findings the coating damage on the pushwire appeared to have been caused by mechanical scraping and abrasion by the pin vise (torque device). In addition, the damages observed on the ancillary devices indicate excessive force such as pushing and pulling was used. In this event, user error may have contributed to the reported issues as the physician continued to advance the device despite of the gradual increase of resistance. Per the instructions for use (ifu): the user should ¿discontinue delivery of the device if high force or excessive friction is encou ntered during delivery. Identify the cause of the resistance and remove device and microcatheter simultaneously. Advancement of the ped against resistance may result in device damage or patient injury. Never advance or withdraw an intraluminal device against resistance until the cause of resistance is determined by fluoroscopy. If the cause cannot be determined, withdraw the catheter. Movement of the micro catheter against resistance may result in damage to the microcatheter, or the vessel. ¿ a review of this device lot history record was conducted and no issues were identified that could have contributed to this event. All products are 100% inspected for damage and irregularities during manufacture.
Event Description
Medtronic received information through analysis of the ancillary devices that coating damage was observed on the push wire. It was initially reported that during treatment of an aneurysm located in the ophthalmic segment of the left internal carotid artery the microcatheter was advanced to the middle cerebral artery when the pipeline device became stuck in the distal end of the microcatheter. It was reported that there was a gradual increase of resistance. The physician removed the entire system and introduced a new device and microcatheter to complete the procedure successfully. No patient injury was reported.
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Manufacturer (Section D)
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
MDR Report Key5870595
MDR Text Key51931438
Report Number2029214-2016-00723
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeVE
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 07/15/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/11/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/18/2016
Device Model NumberFA-71375-30
Device Lot Number9708677
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/27/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/15/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/18/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage