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

Catalog Number	400SMTXSFT3H08
Medical Device Problem Code	Failure to Advance (2524)
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
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left transverse sinus venous using penumbra smart coils (smart coils).During the procedure, the physician successfully placed (b)(4) smart coils and (b)(4) coils using a non-penumbra microcatheter.The physician was then unable to advance another smart coil out of its introducer sheath and into hub of the microcatheter.Therefore, the smart coil was removed, and the procedure was completed using a new smart coil and additional coils with the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the embolization coil was intact with the pusher assembly and had offset coil winds near its proximal end.The pusher assembly was kinked approximately 119.0 and 122.0 cm from the proximal end.Conclusions: evaluation of the returned devices revealed the embolization coil had offset coil winds near its proximal end.If the introducer sheath is not properly aligned in the hub of the microcatheter prior to advancement, resistance may be experienced, and offset coil winds may occur.The offset coil winds caused resistance when advancing the smart coil during functional testing.The kinks in the pusher assembly likely occurred due to forceful advancement of the smart coil against resistance.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.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7197820
• Report Number: 3005168196-2018-00146
• Device Sequence Number: 1978815
• Product Code: HCG
• UDI-Device Identifier: 00814548017129
• UDI-Public: 00814548017129
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• 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,Followup
• Report Date (Section B): 12/21/2017

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: 03/07/2022
• Device Catalogue Number: 400SMTXSFT3H08
• Device Lot Number: F74815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Initial Date Received by Manufacturer: 12/21/2017
• Supplement Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 01/16/2018
• Supplement Report FDA Received Date: 05/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR