MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SMART COIL

Model Number	400SMTSFT0308
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2019
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 coils (smart coil).During the procedure, the physician placed smart coils in the target vessel using a non-penumbra microcatheter.The physician then advanced another smart coil using the same microcatheter and attempted to detach it; however, upon actuation of the handle, the coil pulled back into the microcatheter and became stuck.After several attempts, the physician was able to push the smart coil into the aneurysm using a non-penumbra guidewire.The procedure ended at this point as this was the last coil.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report:3005168196-2019-01756.1.Section b.Box 5.Describe event or problem.Results: the pet lock was broken on the proximal end of its pusher assembly and pull tube was retracted.The pusher assembly was kinked in multiple locations.The embolization coil was detached from its pusher assembly and not returned.Approximately 10.5 cm of the braided section on the distal shaft of the pusher assembly was exposed.There was no visible damage to the non-penumbra microcatheter.Conclusions: evaluation of the returned smart coil revealed a broken pet lock and a detached embolization coil.If the handle is attached to the proximal end of the pusher assembly and is actuated, the pet lock will likely become broken and the pull wire will be retracted.This will allow the embolization coil to detach from its pusher assembly.The root cause of the coil retracting into the microcatheter could not be determined.Further evaluation revealed the braided distal section on the pusher assembly was exposed.The root cause of this damage could not be determined.Further evaluation of the returned smart coil revealed that the pusher assembly was kinked in multiple location.These kinks were likely incidental to the reported complaint.Evaluation of the non-penumbra microcatheter revealed that the distal tip of the catheter was occluded.A stainless-steel mandrel could not be advanced through the returned catheter.In addition, the catheter could not be flushed with fluids.The root cause of the occluded non-penumbra microcatheter could not be determine.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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the coil retracting into the microcatheter.H3 other text : placeholder.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coil).During the procedure, the physician placed smart coils in the target vessel using a non-penumbra microcatheter.The physician then advanced another smart coil using the same microcatheter and attempted to detach it; however, upon actuation of the handle, the coil pulled back into the microcatheter and detached.Subsequently, the coil became stuck and after several attempts, the physician was able to push the smart coil into the aneurysm using a non-penumbra guidewire.The procedure ended at this point as this was the last coil.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9077665
• Report Number: 3005168196-2019-01756
• Device Sequence Number: 3169401
• Product Code: HCG
• UDI-Device Identifier: 00814548015057
• UDI-Public: 00814548015057
• Combination Product (Y/N): Y
• Initial Reporter Country: EC
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2019
• 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: Health Professional
• Device Expiration Date: 06/21/2023
• Device Model Number: 400SMTSFT0308
• Device Catalogue Number: 400SMTSFT0308
• Device Lot Number: F84250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/18/2019
• Supplement Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 01/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Date Report Sent to FDA: 01/01/2005