MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA COIL 400; HCG, KRD

Catalog Number	4004J7
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/23/2018
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.This report is associated with mfr report numbers: 3005168196-2018-02497, 3005168196-2018-02499.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coils 400s (pc400s) and a px slim delivery microcatheter (px slim).During the procedure, the physician was unable to advance two pc400s through the px slim.Therefore, the pc400s and px slim were removed.The procedure was completed using new pc400s and a new px slim.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: for both pc400s, the pet locks were intact on the proximal end of the pusher assembly.The embolization coils were intact with the distal tip of the pusher assembly and were undamaged.Conclusions: evaluation of the returned px slim revealed that the device was ovalized at its distal tip.If the device is forcefully gripped or pinched during preparation, damage such as an ovalization may occur.During the functional testing, the embolization coil could not be advanced through out of the distal tip of px slim due to the ovalizations.Evaluation of the two pc400 revealed that the two devices were undamaged.During the functional testing, the embolization coils were advanced through their introducer sheath and a demonstration px slim without an issue.The px slim ovalization caused the inability to advance the pc400s experienced during the procedure.Penumbra catheters and coils 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.This report is associated with mfr report numbers: 3005168196-2018-02497 and 3005168196-2018-02499.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8190168
• Report Number: 3005168196-2018-02498
• Device Sequence Number: 13952497
• Product Code: HCG
• UDI-Device Identifier: 00814548011318
• UDI-Public: 00814548011318
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2018
• 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: Health Professional
• Device Expiration Date: 07/26/2023
• Device Catalogue Number: 4004J7
• Device Lot Number: C03029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/26/2018
• Supplement Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 03/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Date Report Sent to FDA: 01/01/2005