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

Catalog Number	PXSLIM045
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the returned device was fractured approximately 148.0 cm from the hub.The reported complaint did not involve device functionality; therefore, no functional testing was performed.Conclusions: evaluation of the returned device revealed the px slim was fractured on its distal tip.This damage typically occurs if the device is forcefully retracted against resistance.It was reported that the distal tip of the device was stuck to the packaging.If the device became stuck this would likely contribute to the reported resistance.The device being stuck could not be confirmed and root cause could not be determined.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
During preparation for a coil embolization procedure, the physician noticed that the tip of the px slim delivery microcatheter (px slim) was stuck to the material of the cover upon removal from the packaging.The damage to the px slim occurred prior to use and, therefore, the px slim was not used in the procedure.The procedure was completed using a new px slim.

• Brand Name: PX SLIM DELIVERY MICROCATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8032927
• Report Number: 3005168196-2018-02045
• Device Sequence Number: 1464181
• Product Code: DQY
• UDI-Device Identifier: 00814548016412
• UDI-Public: 00814548016412
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• PMA/510(K) Number: K100826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/23/2018
• Report Date (Section F): 01/01/2005

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: Health Professional
• Device Expiration Date: 08/30/2019
• Device Catalogue Number: PXSLIM045
• Device Lot Number: F71362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005