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

Catalog Number	4006U0204
Medical Device Problem Codes	Stretched (1601); Material Deformation (2976); Unintended Movement (3026)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2017
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 pusher assembly was kinked in multiple locations.The embolization coil was intact with the pusher assembly and had minor offset coil winds.There was no visible stretching or unraveling of the embolization coil.Conclusions: evaluation of the returned device revealed that it had minor offset coil winds, but no visible stretching or unraveling.This damage may have occurred during attempts to retract the pc400 prior to deflating the balloon catheter and retracting the px slim.The presence of the inflated balloon catheter may have contributed to the difficulty experienced during retraction.The pc400 was advanced and retracted through a demonstration px slim during functional testing, with only minor resistance encountered when advancing the kinked regions of the pusher assembly into the px slim.The pusher assembly kinks were likely incidental and may have occurred during packaging for return to penumbra.The pc400 introducer sheath, the px slim, and the non-penumbra balloon catheter mentioned in the complaint were not returned for evaluation.Penumbra coils and catheters 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
The patient was undergoing a coil embolization procedure in the supraclinoid segment of the internal carotid artery (ica) using penumbra coil 400''s (pc400''s).During the procedure, the physician successfully deployed and detached three initial pc400''s into the patient using a px slim delivery microcatheter (px slim).The non-penumbra balloon was partially deflated and while attempting to deploy a new pc400, the physician thought that the coil had unintentionally detached and started pulling back the px slim.However, the pc400 came with the px slim and "popped out" of the aneurysm under tension.The physician reported that the pc400 became "stretched" and wrapped around the px slim.Therefore, the physician removed the balloon catheter, px slim and pc400 all together.There was no noticeable damage to the px slim.The procedure was then completed using additional pc400''s.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: 7204179
• Report Number: 3005168196-2018-00174
• Device Sequence Number: 1276751
• Product Code: HCG
• UDI-Device Identifier: 00814548011370
• UDI-Public: 00814548011370
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 12/20/2017

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: 04/02/2019
• Device Catalogue Number: 4006U0204
• Device Lot Number: C03461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2017
• Initial Report FDA Received Date: 01/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR