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

Model Number	400SMTXSFT0206
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	04/15/2020
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 coils).During the procedure, it was reported that a smart coil would not advance normally through the microcatheter and, therefore, it was removed.The procedure was completed using new smart coils.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils) and non-penumbra microcatheter.During the procedure, the physician placed multiple smart coils were placed in the target vessel using the microcatheter.While advancing another smart coil through the microcatheter, the physician experienced resistance and, therefore, the smart coil was removed.The procedure was completed using new smart coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra sales representative on 05/08/2020: 2.Section h.Box 6.Device code 1.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.Bends and kinks were present throughout the length of the pusher assembly.The embolization coil was intact with the pusher assembly and had offset coil winds along its length.Conclusions: evaluation of the returned smart coil revealed offset coil winds along the length of the embolization coil.If the device is forcefully advanced against resistance, damage such as offset coil winds may occur.During functional testing, after re-sheathing the smart coil properly, resistance was experienced while attempting to advance the smart coil within its introducer sheath due to the offset coil winds and the smart coil could not advance at all.The non-penumbra microcatheter identified in the complaint was not returned for evaluation; therefore, the root cause of resistance during the procedure could not be determined.Further evaluation revealed pusher assembly kinks.These damages were likely incidental to the reported complaint 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: 10036793
• Report Number: 3005168196-2020-00623
• Device Sequence Number: 2714383
• Product Code: HCG
• UDI-Device Identifier: 00814548016030
• UDI-Public: 00814548016030
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 04/15/2020
• 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: 03/05/2024
• Device Model Number: 400SMTXSFT0206
• Device Catalogue Number: 400SMTXSFT0206
• Device Lot Number: F88908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/15/2020
• Supplement Date Received by Manufacturer: 05/08/2020; 06/18/2020
• Initial Report FDA Received Date: 05/07/2020
• Supplement Report FDA Received Date: 05/15/2020; 07/14/2020
• 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