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

Catalog Number	400SMTSFT0306
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2018
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 using penumbra smart coil (smart coil).During the procedure, the physician successfully placed multiple smart coils in the target vessel using a non-penumbra microcatheter.Next, the physician attempted to advance another smart coil out of its introducer sheath and into the microcatheter; however, the smart coil would not advance and therefore, was removed.The procedure was completed using additional smart coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly (figure 2).The embolization coil was intact with the distal detachment tip (ddt) and damaged on its proximal end.The pusher assembly had bends at approximately 11.0 cm, 53.0 cm and 63.0 cm from the proximal end of the pusher assembly.The pusher assembly was kinked approximately 42.0 cm from the proximal end of the pusher assembly.During functional testing, the returned smart coil was able to advance through the demonstration introducer sheath and demonstration microcatheter with minor resistance.Conclusions: evaluation of the returned device revealed an embolization coil with some proximal damage.If the introducer sheath is not properly aligned in the hub of the microcatheter prior to advancement, resistance may be experienced, and the embolization coil may become damaged.Further evaluation revealed kinks and bends along the length of the pusher assembly.Some of these kinks and bends were likely a result of forcefully advancing the device against the initial resistance experienced during the procedure.Most of the kinks and bends on the returned device were likely incidental and may have occurred during packaging for return to penumbra.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: 8001726
• Report Number: 3005168196-2018-02128
• Device Sequence Number: 13799620
• Product Code: HCG
• UDI-Device Identifier: 00814548015040
• UDI-Public: 00814548015040
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2018
• 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: Health Professional
• Device Expiration Date: 02/25/2023
• Device Catalogue Number: 400SMTSFT0306
• Device Lot Number: F82075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/28/2018
• Supplement Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005