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

Catalog Number	4004J25
Medical Device Problem Codes	Bent (1059); Detachment Of Device Component (1104); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Results: the pet lock was broken on the proximal end of the penumbra coil 400 (pc400) pusher assembly, and the pull wire was withdrawn out of the pusher assembly hypotube.The pusher assembly was kinked approximately 77.0 cm from the proximal end.The embolization coil was detached from the pusher assembly and had the proximal constraint sphere intact.Conclusions: evaluation of the returned device revealed the pusher assembly was kinked and the pet lock was broken.This damage may have occurred due to forceful handling of the pc400 during removal from the packaging hoop.If the pet lock becomes broken, it will allow the pull wire to withdraw out of the distal detachment tip (ddt), which would 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 technician opened the packaging of the penumbra coil 400 (pc400) and it was noticed that the pc400 pusher assembly was bent in half and the pc400 was detached from its pusher assembly.The pc400 was removed from its dispenser hoop and confirmed to be detached.The detached pc400 was found prior to use and therefore, was not used for the procedure.The procedure was completed using a new pc400 without any issues.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6684709
• Report Number: 3005168196-2017-01072
• Device Sequence Number: 44030
• Product Code: HCG
• UDI-Device Identifier: 00814548011721
• UDI-Public: 00814548011721
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 06/05/2017

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: Other Health Care Professional
• Device Expiration Date: 02/07/2025
• Device Catalogue Number: 4004J25
• Device Lot Number: F74369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2017
• Initial Report FDA Received Date: 07/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1