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

Catalog Number	PXSLIM045
Medical Device Problem Code	Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/07/2017
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 number: 3005168196-2017-01696.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior m2 segment of the middle cerebral artery (mca) using penumbra coil 400's (pc400s) and a px slim delivery microcatheter (px slim).It was noted that the patient¿s anatomy was tortuous.During the procedure, the physician deployed and detached two pc400s into the target vessel using the px slim with no issues.While attempting to advance a new pc400 through the px slim, the physician experienced resistance and subsequently, the pc400 became stuck.Therefore, the physician removed the px slim with the pc400 and completed the procedure using a non-penumbra microcatheter and penumbra smart coils (smart coils).There was no report of an 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: 6909918
• Report Number: 3005168196-2017-01695
• Device Sequence Number: 13483867
• Product Code: DQY
• UDI-Device Identifier: 00814548016405
• UDI-Public: 00814548016405
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K100826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/07/2017

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: 05/05/2019
• Device Catalogue Number: PXSLIM045
• Device Lot Number: F69207
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2017
• Initial Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR