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

Catalog Number	PXSLIM045-A
Medical Device Problem Codes	Kinked (1339); Physical Resistance (2578); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/20/2016
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: 3005168196-2016-00199.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure for a coronary fistula using ruby coils and a px slim delivery microcatheter (px slim).During the procedure, the physician had difficulty accessing the fistula; however, after manipulation, the physician was able to gain access and advance the px slim into the target vessel.While advancing a ruby coil through the px slim, the physician met resistance and noticed a kink on the px slim.The physician continued to forcefully advance the ruby coil through the px slim.Subsequently, the ruby coil unintentionally detached inside the px slim.The physician decided to remove the px slim containing the ruby coil from the patient and planned to treat the patient in three months.After removing the devices, the physician noticed that the tip of the px slim was damaged.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: 5442572
• Report Number: 3005168196-2016-00200
• Device Sequence Number: 593063
• Product Code: DQY
• UDI-Device Identifier: 00814548016405
• UDI-Public: 00814548016405
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 01/20/2016

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: 08/31/2018
• Device Catalogue Number: PXSLIM045-A
• Device Lot Number: F65255
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2016
• Initial Report FDA Received Date: 02/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR