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

Catalog Number	4002C2060
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/20/2016
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a cervical spinal dural arteriovenous fistula (avf) at the c2 level using penumbra coil 400''s (pc400¿s).During the procedure, the physician deployed a pc400 into the target vessel using a benchmark 6f 071 delivery catheter (benchmark dc) but was unable to detach the coil using a penumbra coil 400 detachment handle (handle).Therefore, the pc400 was removed and the procedure was completed using additional coils and the same handle.There was no report of an adverse effect to the patient.As of (b)(6) 2017, the patient is doing ok, walking again and almost back to normal.
Additional Manufacturer Narrative
Please note that the device in complaint was expected to be returned; however, additional information received from the penumbra clinical research associate indicated that the hospital no longer has the device available for return.Therefore, 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.The device is no longer available for return.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6322092
• Report Number: 3005168196-2017-00175
• Device Sequence Number: 18943322
• Product Code: HCG
• UDI-Device Identifier: 00814548010762
• UDI-Public: 00814548010762
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2017

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: 07/31/2022
• Device Catalogue Number: 4002C2060
• Device Lot Number: F44890
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/12/2017
• Supplement Date Received by Manufacturer: 09/19/2017
• Initial Report FDA Received Date: 02/10/2017
• Supplement Report FDA Received Date: 10/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR