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

Model Number	400SMTXSFT3H08
Medical Device Problem Codes	Stretched (1601); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2020
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 in the m2 segment of the middle cerebral artery (mca) using a smart coil and a non-penumbra microcatheter.During the procedure, the physician experienced resistance while advancing the smart coil into the target vessel and subsequently, the smart coil became stuck at the end of the placement.Therefore, the physician decided to reposition the smart coil.While repositioning the smart coil, the physician noticed under fluoroscopy that the smart coil looked thinner within the coil body.The smart coil stretched and was just connected through the inner wire.Therefore, the physician removed the smart coil by carefully pulling back the pusher assembly.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.Bends were present along the pusher assembly.The embolization coil was intact with the pusher assembly and had offset coil winds on its proximal and distal end.Conclusions: evaluation of the returned smart coil revealed offset coil winds on the proximal and distal tip of the embolization coil.This damage was likely the reported coil stretch.If the device is manipulated against resistance, damage such as offset coil winds may occur.The smart coil was advanced through a demonstration microcatheter without an issue during functional testing.Further evaluation revealed bends along the pusher assembly.This damage was 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: 10321012
• Report Number: 3005168196-2020-01012
• Device Sequence Number: 3178255
• Product Code: HCG
• UDI-Device Identifier: 00814548017129
• UDI-Public: 00814548017129
• Combination Product (Y/N): Y
• Initial Reporter Country: AU
• 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): 06/30/2020
• 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: 07/30/2022
• Device Model Number: 400SMTXSFT3H08
• Device Catalogue Number: 400SMTXSFT3H08
• Device Lot Number: F78416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 10/27/2020
• 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