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

Catalog Number	400SMTSFT0715
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/22/2019
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: 3005168196-2019-00759.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the posterior communicating artery (pcom) using penumbra smart coils (smart coil).During the procedure, the physician successfully placed two smart coils and a non-penumbra stent in the target vessel using a non-penumbra microcatheter.While advancing a new smart coil, the physician experienced resistance and was unable to advance the coil through the microcatheter.Therefore, the smart coil was removed.Next, the physician attempted to advance a new smart coil; however, experienced resistance and the smart coil became stuck inside of the microcatheter and, therefore, it was removed.It was reported that the physician noticed a kink in the microcatheter and was unable to advance new smart coils and other additional coils.The access to the aneurysm would be lost if the microcatheter was to be removed; therefore, the physician decided to end the procedure.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.The embolization coil was intact with the pusher assembly and had offset coil winds.The pusher assembly mid-joint was tested with a 0.0159¿ ring gauge and was within specification.Conclusions: evaluation of the returned smart coils revealed functional devices with some offset coil winds.During functional testing, both smart coils were able to advance through a demonstration microcatheter without issue.Further evaluation revealed ovalizations on the non-penumbra microcatheter.A demonstration smart coil was advanced into the returned non-penumbra microcatheter and was unable to advance past the ovalizations on the microcatheter.These ovalizations likely contributed to the reported resistance during the procedure and during functional testing.If a smart coil is forcefully advanced against resistance, damage such as offset coil winds may occur.The offset coil winds on the returned smart coils were likely a result of advancing them through the damaged non-penumbra microcatheter.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.This report is associated with mfr report number: 1.3005168196-2019-00759.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8532492
• Report Number: 3005168196-2019-00758
• Device Sequence Number: 13860292
• Product Code: HCG
• UDI-Device Identifier: 00814548014722
• UDI-Public: 00814548014722
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2019
• 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: 04/15/2023
• Device Catalogue Number: 400SMTSFT0715
• Device Lot Number: F82853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/22/2019
• Supplement Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 07/03/2019
• 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