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

Catalog Number	PXSLIM045
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right inferior epigastric artery using a px slim delivery microcatheter (px slim).It was noted that the patient's anatomy was tortuous.During the procedure, while attempting to advance the px slim through a non-penumbra guide catheter, the physician experienced resistance and subsequently, the px slim became stuck.Therefore, the physician removed the px slim and successfully completed the procedure using another microcatheter, the same guide catheter and new coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the px slim delivery microcatheter (px slim) was kinked approximately 42.0 and 146.0 cm from the hub.During functional analysis, the px slim could not be advanced pass the kink in the non-penumbra guide catheter.Conclusions: evaluation of the returned devices revealed that the non-penumbra guide catheter was kinked.This damage likely contributed to the resistance experienced during the procedure.Further evaluation revealed that the px slim was also kinked.This damage likely occurred due to forceful advancement into the damaged guide catheter.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.

• Brand Name: PX SLIM DELIVERY MICROCATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7088071
• Report Number: 3005168196-2017-02147
• Device Sequence Number: 13723097
• 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,Followup
• Report Date (Section B): 11/07/2017

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: 01/13/2020
• Device Catalogue Number: PXSLIM045
• Device Lot Number: F73758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Initial Date Received by Manufacturer: 11/07/2017
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 03/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR