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

Catalog Number	4006U0204
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was disposed of by the hospital and is no longer available for return.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 numbers: 3005168196-2017-01737, 3005168196-2017-01739.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right internal thoracic artery using penumbra coil 400's (pc400s) and a px slim delivery microcatheter (px slim).During the procedure, the physician advanced a non-penumbra angiographic catheter towards the target vessel and then attempted to advance the px slim through the catheter; however, resistance was encountered and after advancing the px slim approximately fifty centimeters into the catheter, the physician was unable to advance the px slim any further.The physician then switched to another non-penumbra angiographic catheter and successfully advanced the same px slim through the catheter.Next, the physician deployed and detached nine pc400s into the target vessel using the px slim.While attempting to advance a new pc400 through the px slim, the physician experienced resistance and was unable to advance the coil.Therefore, the physician removed the pc400 and attempted to advance a new pc400 through the px slim; however, resistance was encountered again and the new pc400 would not advance at all.Therefore, the pc400 and px slim were both removed and the procedure was completed using two additional pc400s and a new px slim.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: 6943277
• Report Number: 3005168196-2017-01738
• Device Sequence Number: 682847
• Product Code: HCG
• UDI-Device Identifier: 00814548011370
• UDI-Public: 00814548011370
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120330
• 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
• Report Date (Section B): 09/13/2017

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: 03/31/2021
• Device Catalogue Number: 4006U0204
• Device Lot Number: F33908
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 10/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 2 YR
• Patient Weight: 11