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

Catalog Number	400SMTHXSFT0202
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2019-00587.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal carotid-posterior communicating artery (ic-pc) using penumbra smart coils (smart coils) and a penumbra smart coil detachment handle (handle).During the procedure, the physician successfully implanted three non-penumbra coils into the target vessel coils using a non-penumbra microcatheter.Subsequently, the physician implanted two smart coils using the handle and the microcatheter.The physician then advanced the sixth coil, a smart coil, into the target vessel and failed to detach it using the handle.It was reported that the black alignment zone (pet lock) was pushed too far into the handle and unable to be repositioned.The smart coil and the handle were therefore removed and were no longer used in the procedure.The procedure was completed using four other coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was separated on the proximal end of the pusher assembly.The pusher assembly was kinked along its length.The pull wire was pulled out of the distal detachment tip.The embolization coil was detached from the pusher assembly and not returned for evaluation.Introducer sheath was not returned with the device.Conclusions: evaluation of the returned smart coil pusher assembly revealed the pet lock was separated and embolization coil was detached.If the handle is used during the process of coil detachment, the pet lock will separate.If the pet lock is separated, the pull wire will get pulled out of the distal detachment tip (ddt) and the embolization coil will be detached from the ddt.The detached embolization coil was not returned with the pusher assembly.The reported failure of embolization coil detachment could not be confirmed.Evaluation of the returned handle revealed an undamaged device.During the functional testing, the handle was tested with the test fixture and the result was within specification.Penumbra coils and handles 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.This report is associated with mfr report number: 1.3005168196-2019-00587.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8460384
• Report Number: 3005168196-2019-00586
• Device Sequence Number: 2746359
• Product Code: HCG
• UDI-Device Identifier: 00814548015699
• UDI-Public: 00814548015699
• Combination Product (Y/N): Y
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2019
• Report Date (Section F): 01/01/2005

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: No Information
• Device Expiration Date: 12/26/2021
• Device Catalogue Number: 400SMTHXSFT0202
• Device Lot Number: F73337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 04/19/2019
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 05/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Date Report Sent to FDA: 01/01/2005