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

Catalog Number	PXSLIMSTR
Medical Device Problem Code	Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/17/2017
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.This report is associated with mfr report numbers: 3005168196-2017-00458; 3005168196-2017-00459.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left transverse sinus venous using penumbra coil 400's (pc400's) and a px slim delivery microcatheter (px slim).During the procedure, the physician placed a non-penumbra guide catheter and a non-penumbra microcatheter into the target vessel and then implanted eight non-penumbra coils.Next, the physician switched to the px slim and attempted to advance a pc400 through it.While attempting to advance the pc400, the physician encountered resistance and was unable to advance the pc400 out of its introducer sheath and into the px slim.Therefore, the introducer sheath containing the pc400 was removed and a new pc400 was opened.While attempting to advance the new pc400 through the same px slim, the physician encountered resistance after advancing the coil approximately one hundred centimeters through the px slim.Therefore, the px slim containing the pc400 was removed.The procedure was then completed using an additional coil and a non-penumbra microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: there was no visible damage to the px slim delivery microcatheter (px slim).Conclusions: evaluation of the returned devices revealed that both pc400 introducer sheaths were re-loaded backwards on the pusher assemblies.If the introducer sheath is re-loaded backwards on the pusher assembly, resistance will likely be experienced upon attempting to advance the pc400 out of the introducer sheath, and the embolization coil may become compressed.Since the complaint reported that the second pc400 was successfully advanced into the px slim, the backwards-loaded introducer sheath was likely incidental and likely occurred after successfully withdrawing the pc400 from the px slim and patient.Further evaluation revealed that once the second pc400¿s backwards-loaded introducer sheath was re-loaded in the correct orientation, the pc400 could be successfully advanced through a demonstration px slim without issue.The kink observed on the second pc400 pusher assembly was likely incidental and may have occurred during packaging for return to penumbra.The px slim and handle had no visible damage, and a 0.025¿ mandrel could be advanced through the px slim without issue.The non-penumbra guide catheter and microcatheter mentioned in the complaint were not returned for evaluation.Penumbra coils and 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: 6437870
• Report Number: 3005168196-2017-00460
• Device Sequence Number: 18946184
• 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): 02/26/2017

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: 05/20/2019
• Device Catalogue Number: PXSLIMSTR
• Device Lot Number: F69397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/26/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2017
• Supplement Report FDA Received Date: 05/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1