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

Catalog Number	4004C0615
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the first penumbra coil 400 (pc400) evaluated.The pusher assembly was kinked approximately 5.0 and 30.0 cm from the proximal end of the pusher assembly.The embolization coil¿s stretch resistant wire (sr wire) was fractured.The outer diameter (od) was measured and found to be within specification.Conclusions: evaluation of the returned devices revealed that the non-penumbra microcatheter was ovalized approximately 22.0 thru 27.0 cm from the hub.This damage may cause difficulty during advancement of the pc400s.A soft pc400 in particular would likely have extreme difficulties advancing through an ovalized microcatheter.The ods of both pc400s were measured and found to be within specification, and the second pc400 evaluated was advanced through a demonstration px slim, and functioned as intended.The pc400s being used with the damaged non-penumbra microcatheter was likely the root cause of the resistance encountered by the physician during advancement.Further evaluation revealed that the first pc400¿s sr wire was fractured, and the embolization coil was detached.This damage likely occurred from forceful retraction of the embolization coil through the ovalized non-penumbra microcatheter.The non-penumbra microcatheter was kinked below the hub.This kink was likely incidental and may have occurred during packaging the device for return.Penumbra coils are visually 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 left internal iliac artery (iia) using penumbra coil 400''s (pc400's).During the procedure, the physician deployed and detached two standard pc400's into the target vessel using another manufacturer's microcatheter.While attempting to advance a new soft pc400 through the microcatheter, the physician encountered resistance after advancing the coil twenty centimeters from the hub of the microcatheter and was unable to advance the coil further.Therefore, the pc400 was removed and another new soft pc400 was opened.While attempting to advance the new pc400 through the microcatheter, the physician encountered resistance again and was unable to advance the coil further.Therefore, the soft pc400 was removed and the procedure was successfully completed using a new standard pc400 and the same microcatheter.It should be noted that the physician did not use a rotating hemostasis valve (rhv) and did not maintain a continuous flush but did flush the microcatheter before each pc400 used during the procedure.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: 6251649
• Report Number: 3005168196-2017-00055
• Device Sequence Number: 16385614
• Product Code: HCG
• UDI-Device Identifier: 00814548010885
• UDI-Public: 00814548010885
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/14/2016

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: 07/26/2023
• Device Catalogue Number: 4004C0615
• Device Lot Number: F65056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2016
• Initial Report FDA Received Date: 01/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1