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

Catalog Number	4004C1145
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pusher assembly of the second penumbra coil 400 (pc400) had minor bends in multiple locations.The embolization coil was intact with the pusher assembly and had offset coil windings.Conclusions: evaluation of the returned devices revealed both pc400s could be advanced through their introducer sheaths and a demonstration microcatheter without issue once dried blood was flushed out of the introducer sheaths.The root cause of the inability to advance the pc400s during the procedure could not be determined.Further evaluation revealed the second pc400¿s embolization coil had offset coil windings.This type of damage typically occurs due to forceful advancement of the pc400 against resistance.The lantern mentioned in the complaint was 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 to treat a splenic aneurysm using penumbra coil 400s (pc400s).During the procedure, the physician successfully deployed and detached the initial coils in the target vessel using a lantern delivery microcatheter (lantern).While attempting to advance two pc400s through the lantern, the pc400s would not advance out of their introducer sheaths and into the microcatheter.After many failed attempts, the pc400s were removed.The procedure was completed using additional coils.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: 6406250
• Report Number: 3005168196-2017-00364
• Device Sequence Number: 19032156
• Product Code: HCG
• UDI-Device Identifier: 00814548011004
• UDI-Public: 00814548011004
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2017

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: 08/31/2022
• Device Catalogue Number: 4004C1145
• Device Lot Number: F60404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2017
• Initial Report FDA Received Date: 03/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR