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

Model Number	400SMTXSFT0206
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2020
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.This report is associated with mfr report numbers: 3005168196-2020-01384, 3005168196-2020-01385, 3005168196-2020-01387, 3005168196-2020-01388, 3005168196-2020-01389, 3005168196-2020-01390.
Event or Problem Description
The patient was undergoing a coil embolization procedure for an arteriovenous malformation (avm) using penumbra smart coils (smart coils), penumbra smart coil detachment handle (handle), a benchmark 6f 071 delivery catheter (benchmark), and non-penumbra microcatheter.During the procedure, the physician advanced five smart coils separately into the avm and clicked on the handle.It was reported that the physician switched to a second handle after experiencing this issue with two to three smart coils; however, the second handle failed to detach the remaining smart coils.The pusher assembly of each smart coil indicated the smart coil was detached correctly, but both handle failed to detach five smart coils.Therefore, the smart coils and handle were removed.The procedure was completed using non-penumbra smart coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was separated and damaged on the proximal end of the pusher assembly.The pusher assembly had a bend on its proximal shaft.The embolization coil was intact with the pusher assembly.During functional testing, the smart coil was detached using the returned handle without an issue.Conclusions: evaluation of the second returned smart coil revealed that the pet lock was separated and damaged on the proximal end of the pusher assembly, and the embolization coil was intact with the pusher assembly.If the proximal end of the pusher assembly is forcefully inserted into a handle, the proximal end of the pet lock may become damaged.If this occurs, the pull tube may not retract completely when the handle is actuated, and the embolization coil will not detach.Further evaluation revealed bends and kinks along the pusher assembly and offset coil winds.This damage may be incidental to the reported complaint.Evaluation of the third returned smart coil revealed that the pet lock was separated and damaged on the proximal end of the pusher assembly, and the embolization coil was intact with the pusher assembly.If the proximal end of the pusher assembly is forcefully inserted into a handle, the proximal end of the pet lock may become damaged.If this occurs, the pull tube may not retract completely when the handle is actuated, and the embolization coil will not detach.Further evaluation revealed a bend on the pusher assembly.This damage was likely incidental to the reported complaint.Evaluation of the fifth returned smart coil revealed that the pet lock was separated and damaged on the proximal end of the pusher assembly, and the embolization coil was intact with the pusher assembly and dried blood was within the ddt.If the proximal end of the pusher assembly is forcefully inserted into a handle, the proximal end of the pet lock may become damaged.If this occurs, the pull tube may not retract completely when the handle is actuated, and the embolization coil will not detach.Further evaluation revealed bends and kinks along the pusher assembly and offset coil winds.This damage may be incidental to the reported complaint.Evaluation of the returned handle revealed an undamaged, functional device.During functional testing, the handle successfully detached second and third smart coils without an issue.While attempting to detach fifth smart coil, the handle was actuated, and the proximal end of the pusher assembly became stuck within the handle, and the embolization coil did not detach due to the coagulated blood.The nose cone was removed from the handle body and the pet lock was observed to be further damaged on the proximal end of the pusher assembly.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 numbers: 3005168196-2020-01384; 3005168196-2020-01385; 3005168196-2020-01387; 3005168196-2020-01388; 3005168196-2020-01389; 3005168196-2020-01390.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10497023
• Report Number: 3005168196-2020-01386
• Device Sequence Number: 11434782
• 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
• Report Date (Section B): 08/13/2020
• 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: 04/27/2025
• Device Model Number: 400SMTXSFT0206
• Device Catalogue Number: 400SMTXSFT0206
• Device Lot Number: F97579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 09/04/2020
• Supplement Report FDA Received Date: 11/20/2020
• 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