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

Model Number	400SMTXSFT2H06
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2020
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a dural arteriovenous fistula (davf) using penumbra smart coils (smart coils), non-penumbra coils, a non-penumbra microcatheter and n-butyl cyanoacrylate (nbca).It was reported that the patient anatomy was slightly tortuous and mildly calcified.During the procedure, 13% nbca was injected and a coil was placed into the target vessel using the microcatheter.The physician then advanced a smart coil through the microcatheter into the target vessel but decided to retract the smart coil for recoiling.While retracting, the physician experienced resistance, and the smart coil unintentionally detached inside the microcatheter.Therefore, the microcatheter containing the detached smart coil was removed, and the smart coil was flushed out.The procedure was completed using two additional smart coils, six other coils, and the same microcatheter.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 had bends and kinks throughout its length.The pull wire was not within the pusher assembly distal detachment tip (ddt) alignment feature.The embolization coil was detached from the pusher assembly and had offset coil winds along its length.Conclusions: evaluation of the returned smart coil confirmed a detached embolization coil and revealed that the pull wire was not within the ddt alignment feature.If the device is forcefully retracted against resistance, the pusher assembly may elongate, and the embolization coil will detach.Further evaluation revealed the pet lock was separated on the proximal end of the pusher assembly, offset coil winds on the embolization coil and bends and kinks along the length of the pusher assembly.These damages were likely incidental to the reported complaint.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: 9702690
• Report Number: 3005168196-2020-00135
• Device Sequence Number: 2474913
• Product Code: HCG
• UDI-Device Identifier: 00814548015330
• UDI-Public: 00814548015330
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2020
• 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: 02/14/2023
• Device Model Number: 400SMTXSFT2H06
• Device Catalogue Number: 400SMTXSFT2H06
• Device Lot Number: F81915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Date Report Sent to FDA: 01/01/2005