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

Catalog Number	PXSLIMSTR
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/27/2017
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 abdominal aortic artery (aaa) using a px slim delivery microcatheter (px slim).During the procedure, while attempting to advance the px slim through a non-penumbra microcatheter, the physician encountered resistance at the hub of the microcatheter.Therefore, the px slim was removed and the embolization was successfully completed using a new microcatheter and additional coils.Thereafter, the procedure shifted to a stent-grafting and was completed without any issues.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 17.0, 78.0, 82.0, and 115.0 cm from the hub.The outer diameter (od) of the px slim was measured and found to be within specification.During functional analysis, a stainless steel mandrel was advanced through the px slim, and resistance was encountered upon advancing through the kinked regions.The px slim was then inserted into a demonstration penumbra system 3max reperfusion catheter (3max) and extreme resistance was experienced upon advancing the kinked regions of the px slim through the 3max.The kinked region of the px slim located 17.0 cm from the hub could not advance through the hub of the 3max.Conclusions: evaluation of the returned device revealed that it was kinked in multiple locations.This damage may have occurred due to forceful handling of the px slim during preparation for use.The kinked regions likely contributed to the resistance experienced during the procedure, and did cause resistance when advancing the px slim through a demonstration 3max.The non-penumbra catheter mentioned in the complaint was not returned for evaluation.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: 6614529
• Report Number: 3005168196-2017-00860
• Device Sequence Number: 11008202
• Product Code: DQY
• UDI-Device Identifier: 00814548016443
• UDI-Public: 00814548016443
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/08/2017

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: 12/06/2019
• Device Catalogue Number: PXSLIMSTR
• Device Lot Number: F73023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2017
• Initial Date Received by Manufacturer: 05/08/2017
• Supplement Date Received by Manufacturer: 07/05/2017
• Initial Report FDA Received Date: 06/06/2017
• Supplement Report FDA Received Date: 08/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1