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

Catalog Number	4002C2457
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	11/08/2017
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: 3005168196-2017-02175, 3005168196-2017-02176.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right internal iliac artery (iia) using penumbra coil 400''s (pc400''s).It was noted that the patient''s anatomy was mildly tortuous, but no calcification, stenosis or constriction was observed.During the procedure, the physician placed a non-penumbra diagnostic catheter towards the target vessel then advanced a lantern delivery microcatheter (lantern) through the diagnostic catheter.While attempting to advance the first pc400 through the lantern, the physician experienced resistance midway through the lantern and was unable to advance the coil further.Therefore, the pc400 was removed from the lantern and a new pc400 was opened.It was reported that the same issue was encountered with this subsequent pc400 and therefore, the coil was removed from the lantern.After that, the physician successfully deployed and detached a new pc400 into the target vessel using the same lantern.While attempting to advance another pc400 through the lantern, the physician experienced resistance midway through the lantern again and therefore, the pc400 was removed.The lantern was then removed and the procedure was completed using the diagnostic catheter and nine additional coils.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: 7106620
• Report Number: 3005168196-2017-02177
• Device Sequence Number: 782112
• Product Code: HCG
• UDI-Device Identifier: 00814548010809
• UDI-Public: 00814548010809
• 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): 11/12/2017

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: 01/25/2024
• Device Catalogue Number: 4002C2457
• Device Lot Number: F67604
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2017
• Initial Report FDA Received Date: 12/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1