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

Model Number	400SMTXSFT0206
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2020
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 ophthalmic artery using penumbra smart coils (smart coils), non-penumbra coils, and a non-penumbra microcatheter.It was reported that the patient anatomy was tortuous.During the procedure, the physician implanted four smart coils and four non-penumbra coils in the target location.Subsequently, while advancing the next smart coil into the microcatheter, the physician experienced resistance, and the smart coil became stuck at the hub, towards the rotating hemostasis valve.To reduce resistance, the physician manipulated the smart coil back and forth, and the pusher assembly of the smart coil became kinked.Therefore, the smart coil was removed.The procedure was completed using a new smart coil, two non-penumbra coils, and the same microcatheter.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end of the pusher assembly.Kinks were present along the length of the pusher assembly.The pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock and kinked.The embolization coil was undamaged and intact with the pusher assembly.Conclusions: evaluation of the returned smart coil confirmed a pusher assembly kink at its mid-joint.Further evaluation of the device revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If this occurs, resistance will likely be experienced while advancing the device and the device may not be advanced out of the introducer sheath.Forceful advancement against this resistance may result to the kink which was observed on the pusher assembly mid-joint.The smart coil was unable to be advanced from its returned position due to the kink on its pusher assembly mid-joint.Further evaluation of the device also revealed addition kinks along the length of the pusher assembly.This damage was likely incidental to the complaint.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.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10997636
• Report Number: 3005168196-2020-02254
• Device Sequence Number: 14343114
• Product Code: HCG
• UDI-Device Identifier: 00814548016030
• UDI-Public: 00814548016030
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2020
• 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: 10/10/2023
• Device Model Number: 400SMTXSFT0206
• Device Catalogue Number: 400SMTXSFT0206
• Device Lot Number: F81388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 12/13/2020
• Supplement Report FDA Received Date: 01/20/2021
• 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