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

Catalog Number	4006C0308
Medical Device Problem Codes	Stretched (1601); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2019
Type of Reportable Event	Malfunction
Additional 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: 3005168196-2019-02047.
Event or Problem Description
The patient was undergoing a coil embolization procedure with stent assist in the right internal carotid artery (ica) using penumbra coils 400 (pc400s) and a px slim delivery microcatheter (px slim).During the procedure, a non-penumbra stent was placed across the aneurysm, follow by the px slim and a non-penumbra microcatheter, which were advanced through a neuron max 6f 088 long sheath (neuron max).The physician then successfully placed two pc400s in the aneurysm using the px slim.While advancing the next pc400 through the px slim in the aneurysm, it was noticed that the pc400 was too long; the physician experienced resistance and part of the pc400 began falling out of the aneurysm and down into the parent vessel.Subsequently, the physician decided to partially retract the px slim to remove the pc400.Upon removal of the pc400, the physician noticed it was stretched with the coil winds visible.Next, the physician noticed under fluoroscopy that the distal marker on the px slim was located outside the aneurysm; therefore, the physician continued retracting the px slim out from between the stent and the target vessel and attempted to recannulate the aneurysm through the stent, but the markers of the stent had migrated from the original position.The physician decided to end the procedure at this point and will continue the embolization procedure later after the stent is endothelialized.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9275957
• Report Number: 3005168196-2019-02048
• Device Sequence Number: 11677522
• Product Code: HCG
• UDI-Device Identifier: 00814548018195
• UDI-Public: 00814548018195
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/08/2019
• 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 Catalogue Number: 4006C0308
• Device Lot Number: F90229
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 11/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Date Report Sent to FDA: 01/01/2005