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

Model Number	400SMTSTD1460
Medical Device Problem Codes	Failure to Advance (2524); 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	08/25/2020
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 number: 3005168196-2020-01520.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the basilar tip using penumbra smart coils (smart coils) and a non-penumbra microcatheter.During the procedure, while attempting to advance a smart coil out of its introducer sheath, the smart coil became stuck.Subsequently, the physician was unable to retract the smart coil back into its introducer sheath.Therefore, the physician removed the microcatheter containing the smart coil and then removed the smart coil.While attempting to advance another smart coil out of its introducer sheath, the same issue occurred.Therefore, the physician removed the microcatheter containing the smart coil.The procedure was completed using additional smart coils, other coils, and another 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.The embolization coil was intact with the pusher assembly.The pe fibers and stretch resistant wire (sr wire) were fractured, and the embolization coil was unraveled.Bends were present along the length of the pusher assembly.Conclusions: evaluation of the returned smart coil revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If this occurs, resistance will likely be experienced while advancing the device.Forcefully advancing the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 kink observed near the pusher assembly mid-joint.During functional testing, the smart coil was unable to advance from its returned position within the introducer sheath.After properly re-sheathing the device into its introducer sheath, the smart coil was able to be advanced through its introducer sheath and a demonstration microcatheter without an issue.Evaluation of the returned smart coil revealed that the pe fibers and sr wire were fractured, and the embolization coil was unraveled.If the embolization coil is forcefully retracted against resistance, damage such as this may occur.It was reported that the smart coil was stuck within the non-penumbra microcatheter during advancement.This may have contributed to the resistance during retraction.The non-penumbra microcatheter was not returned for evaluation.Further evaluation of the device revealed bends 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.This report is associated with mfr report number: 3005168196-2020-01520 h3 other text : placeholder.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10556568
• Report Number: 3005168196-2020-01521
• Device Sequence Number: 2842851
• Product Code: HCG
• UDI-Device Identifier: 00814548014289
• UDI-Public: 00814548014289
• Combination Product (Y/N): Y
• Initial Reporter State: KS
• 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): 08/25/2020
• 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: 05/17/2022
• Device Model Number: 400SMTSTD1460
• Device Catalogue Number: 400SMTSTD1460
• Device Lot Number: F77196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/25/2020
• Supplement Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 11/14/2020
• 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