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

Catalog Number PXSLIMSTR-B

Device Problems Physical Resistance (2578); Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2016

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 3005168196-2016-00287.The hospital disposed of the device.

Event Description

The patient was undergoing a coil embolization procedure in the left internal iliac artery (iia), superior gluteal artery (sga) and inferior gluteal artery (iga) using penumbra coils 400 (pc400 coils) and a px slim delivery microcatheter (px slim).During the procedure, the physician delivered a total of nine pc400 coils and another manufacturer's coils into the aneurysm using a px slim.While attempting to advance a tenth pc400 coil through the px slim, the physician met resistance and removed the pc400 coil from the patient.While on the back table, the physician confirmed that the pc400 coil could be advanced out of its introducer sheath and manipulated successfully.Therefore, the physician removed the px slim from the patient and attempted to deliver the same pc400 coil using a new px slim; however, resistance was met again and the pc400 coil was removed.While on the back table, the physician attempted to advance the pc400 coil out of its introducer sheath; however, resistance was met and the coil was unable to advance out of its introducer sheath.The procedure was completed using a new pc400 coil and the second px slim.There was no report of an adverse effect to the patient.

• Brand Name: PX SLIM DELIVERY MICROCATHETER
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5484658
• MDR Text Key: 39825703
• Report Number: 3005168196-2016-00288
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016443
• UDI-Public: 00814548016443
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K100826
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: PXSLIMSTR-B
• Device Lot Number: F65286
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 81 YR