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

Catalog Number	4002C0610
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Failure to Advance (2524)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the penumbra coil 400 (pc400) pusher assembly.The introducer sheath was ovalized approximately 58.0 cm from the proximal end.The embolization coil was intact with the pusher assembly.Conclusions: evaluation of the returned device revealed the introducer sheath was ovalized.This damage may have occurred due to forceful gripping or otherwise compressing the introducer sheath during removal from the packaging or preparation for use.The ovalized introducer sheath likely caused the inability to advance the pc400 during preparation.Penumbra 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.
Event or Problem Description
While preparing a penumbra coil 400 (pc400) for a coil embolization procedure, the physician attempted to advance the pc400 out of its introducer sheath on the back table but the coil was unable to advance out.Therefore, the pc400 coil was not used for the procedure.The procedure was completed using a new pc400.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6042376
• Report Number: 3005168196-2016-01490
• Device Sequence Number: 13670004
• Product Code: HCG
• UDI-Device Identifier: 00814548010502
• UDI-Public: 00814548010502
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2016

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: 07/31/2021
• Device Catalogue Number: 4002C0610
• Device Lot Number: F36649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2016
• Initial Report FDA Received Date: 10/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1