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

Model Number	PXSLIM045-A
Medical Device Problem Codes	Mechanical Problem (1384); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/15/2018
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 left ophthalmic carotid artery using a px slim delivery microcatheter (px slim).During the procedure, the physician experienced resistance and was unable to advance a penumbra coil 400 (pc400) through the px slim, and therefore the px slim was removed with the pc400.The physician then re-advanced the same px slim to the target location, and re-attempted to advance the same pc400 through the px slim.However, the pc400 was unable to advance again and therefore the px slim and pc400 were removed from the patient.The procedure was then completed using a new microcatheter, the same pc400, and additional pc400s.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the distal end of the returned px slim was slightly misshaped.Conclusions: evaluation of the returned px slim revealed a small deformation on the distal catheter shaft.This is likely a result of on-label use of the device within distal patient anatomy and was incidental to the reported failure.During functional testing, a demonstration coil was advanced through the subject px slim without issue.The root cause of the reported failure 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.

• Brand Name: PX SLIM DELIVERY MICROCATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7332935
• Report Number: 3005168196-2018-00545
• Device Sequence Number: 16169386
• Product Code: DQY
• UDI-Device Identifier: 00814548016405
• UDI-Public: 00814548016405
• Combination Product (Y/N): Y
• Initial Reporter Country: PE
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2018
• 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: Physician
• Device Expiration Date: 12/22/2019
• Device Model Number: PXSLIM045-A
• Device Catalogue Number: PXSLIM045
• Device Lot Number: F73303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/16/2018
• Supplement Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 03/12/2018
• Supplement Report FDA Received Date: 02/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Date Report Sent to FDA: 01/01/2005