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

Catalog Number	PXSLIM090-A
Medical Device Problem Codes	Kinked (1339); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the strain relief was offset.The offset strain relief was unwound by a penumbra investigator to reveal a fracture of the catheter shaft.The px slim was ovalized approximately 1.0 cm from the distal tip.Conclusions: evaluation of the returned device revealed it was fractured under the strain relief.This type of damage typically occurs due to forceful handling at extreme angles during removal from the packaging or preparation for use.Further evaluation revealed the distal end of the px slim was ovalized.This damage likely occurred due to forceful gripping of the px slim during preparation for use.Px slim devices are 100% visually evaluated during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the vertebral basilar junction using a px slim delivery microcatheter (px slim).During the procedure, the physician noticed that the px slim strain relief was kinked.Shortly after that, the physician noticed that saline was leaking from the area of the strain relief.The px slim was removed from the patient and the procedure was successfully completed using a new px slim.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: 5531923
• Report Number: 3005168196-2016-00392
• Device Sequence Number: 393684
• Product Code: DQY
• UDI-Device Identifier: 00814548010342
• UDI-Public: 00814548010342
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2016

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: 05/31/2016
• Device Catalogue Number: PXSLIM090-A
• Device Lot Number: F35710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2016
• Initial Report FDA Received Date: 03/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR