MAUDE Adverse Event Report: PENUMBRA, INC. PX SLIM DELIVERY MICROCATHETER; DQY

Catalog Number	PXSLIM045-A
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/09/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report numbers: 3005168196-2016-00012, 3005168196-2016-00013, 3005168196-2016-00015.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the ovarian vein using ruby coils and px slim delivery microcatheters (px slim).During the procedure, the physician placed a px slim in the target vessel through another manufacturer's guide catheter.However, the physician was unable to advance a ruby coil through the px slim and they were both removed from the patient.The physician then attempted to advance two new px slim's through a guide catheter and another manufacturer's catheter but both px slim devices would not advance completely out of the catheters and were removed.The physician ended the procedure at this point.It is unknown if there was any adverse effect to the patient.

• Brand Name: PX SLIM DELIVERY MICROCATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5342428
• Report Number: 3005168196-2016-00014
• Device Sequence Number: 10852234
• Product Code: DQY
• UDI-Device Identifier: 00814548016405
• UDI-Public: 00814548016405
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K100826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Report Date (Section B): 12/09/2015

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: Physician
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: PXSLIM045-A
• Device Lot Number: F62900
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1