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

Catalog Number	PXSLIM130
Medical Device Problem Codes	Fracture (1260); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/26/2017
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
During preparation for a thrombectomy procedure, the hospital staff noticed that the px slim delivery microcatheter (px slim) was fractured about 50cm from the tip.The damage to the px slim was noticed prior to use; therefore it was not used in the procedure.The procedure was completed using a new px slim.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the px slim was fractured approximately 35.0, 97.0, and 116.0 cm from the proximal hub.There was slight bends along the length of the catheter shaft.There was a distinct kink approximately 5.0 cm distal to the most distal fracture of the px slim.Conclusions: evaluation of the device revealed several fractures along the px slim catheter shaft and a distinct kink just distal to the most distal fracture.This kink is likely a result of the packaging tray becoming closed on the catheter, therefore, pinning the catheter in the tray.Subsequently, if the catheter is forcefully retracted while pinned, the px slim may become fractured.Further evaluation revealed there were multiple fractures on the catheter shaft.It is unlikely for the catheter to fracture in multiple locations simultaneously.Therefore, one or more of these fractures likely occurred after the initial fracture occurrence.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: 6598411
• Report Number: 3005168196-2017-00822
• Device Sequence Number: 1278886
• Product Code: DQY
• UDI-Device Identifier: 00814548012537
• UDI-Public: 00814548012537
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2017

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: 04/30/2017
• Device Catalogue Number: PXSLIM130
• Device Lot Number: F42568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Initial Date Received by Manufacturer: 05/01/2017
• Supplement Date Received by Manufacturer: 07/06/2017
• Initial Report FDA Received Date: 05/30/2017
• Supplement Report FDA Received Date: 08/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1