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

Catalog Number	4002C1335
Medical Device Problem Codes	Kinked (1339); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was fractured approximately 29.0 cm from the proximal end.The embolization coil was detached from the pusher assembly.Conclusions: evaluation of the returned device revealed the pusher assembly was fractured and the embolization coil was detached.Fracture of the pusher assembly may occur due to forceful handling of the pc400 at extreme angles during removal from the packaging or preparation for use.If the pusher assembly becomes fractured, it may allow the pull wire to withdraw from the distal detachment tip (ddt) and allow the embolization coil to detach.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
During preparation for a coil embolization procedure, the physician noticed that the penumbra coil 400 (pc400) pusher assembly was kinked and the coil was detached upon removal from the packaging hoop.The damage to the pc400 was noticed prior to use and therefore, it was not used in 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: 7277542
• Report Number: 3005168196-2018-00362
• Device Sequence Number: 2300727
• Product Code: HCG
• UDI-Device Identifier: 00814548010656
• UDI-Public: 00814548010656
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Type of Report: Initial
• Report Date (Section B): 01/24/2018

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: 06/09/2023
• Device Catalogue Number: 4002C1335
• Device Lot Number: C00738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2018
• Initial Report FDA Received Date: 02/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1