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

Model Number	400SMTHXSFT0101
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2020
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: 3005168196-2020-01083, 3005168196-2020-01084, 3005168196-2020-01085, 3005168196-2020-01086, 3005168196-2020-01087, 3005168196-2020-01088.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the middle cerebral artery.During the procedure, the patient¿s vessel was perforated using a non-penumbra guidewire.The physician attempted to use penumbra smart coils (smart coils) to stop the bleeding; however, six smart coils would not advance past their initial positions within the introducer sheaths.Therefore, the smart coils were not used in the procedure.The next three smart coils were implanted in the target location using the penumbra smart coil detachment handle (handle).While attempting to implant the next smart coil using the handle, it would not detach.The physician attempted to manually detach the smart coil without success; therefore, this smart coil was removed from the patient.The procedure was completed using five smart coils and the same handle.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was separated approximately 0.3 cm on the proximal end of the pusher assembly.Kinks and bends were present along the length of the pusher assembly.The pull wire was within the pusher assembly distal detachment tip (ddt).The embolization coil was intact with the pusher assembly and had offset coil winds.The introducer sheath was not returned for evaluation.Conclusions: evaluation of the first smart coil revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If this occurs, resistance will likely be experienced while advancing the device.During functional testing, the pusher assembly mid-joint was advanced through the introducer sheath friction lock with resistance.Then the device was able to advance through its introducer sheath and a demonstration microcatheter without an issue.Evaluation of the second smart coil 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.Forcefully advancing the device against this resistance may have contributed to the kinks which were observed on the pusher assembly.During functional testing, the pusher assembly mid-joint was advanced through the introducer sheath friction lock with resistance.Then the device was able to advance through its introducer sheath and a demonstration microcatheter with resistance due to the kinks on the pusher assembly.Evaluation of the third smart coil 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.Forcefully advancing the device against this resistance may have contributed to the kinks which were observed on the pusher assembly.During functional testing, the pusher assembly mid-joint was advanced through the introducer sheath friction lock with resistance.Then the device was able to advance through its introducer sheath and a demonstration microcatheter with resistance due to the kinks on the pusher assembly.Evaluation of the seventh smart coil confirmed that the embolization coil was unable to detached from its pusher assembly.Further evaluation of the device revealed that the pet lock was separated; however, the pull wire was not retracted out of the ddt.If pull wire is not retracted from the ddt, the embolization coil will not detach from the pusher assembly.During functional testing, the embolization coil could not be detached with a demonstration handle.Therefore, the smart coil was attempted to detach manually.While retracting the pull wire from the proximal end of the pusher assembly, resistance was encountered, and the pull wire was unable to retract from the ddt.Therefore, the smart coil could not be manually detached.Further evaluation of the device also revealed kinks and bends on the pusher assembly and offset coil winds on the embolization coil.The kinks and bends may have contributed to the resistance during the functional test.The offset coil winds were 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.This report is associated with mfr report numbers: 3005168196-2020-01083; 3005168196-2020-01084; 3005168196-2020-01085; 3005168196-2020-01086; 3005168196-2020-01087; 3005168196-2020-01088.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10354070
• Report Number: 3005168196-2020-01089
• Device Sequence Number: 3064957
• Product Code: HCG
• UDI-Device Identifier: 00814548015590
• UDI-Public: 00814548015590
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• 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): 07/10/2020
• 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: 05/03/2025
• Device Model Number: 400SMTHXSFT0101
• Device Catalogue Number: 400SMTHXSFT0101
• Device Lot Number: F97660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/10/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 08/01/2020
• Supplement Report FDA Received Date: 10/06/2020
• 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