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

Model Number	400SMTHXSFT0203
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2020-00391.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (acom) using penumbra smart coils (smart coils).During the procedure, while attempting to advance a smart coil through the rotating hemostasis valve (rhv), the physician experienced resistance, and the smart coil would not advance further; therefore, it was removed.The next smart coil had the same issue; therefore, it was also removed.The procedure was completed using another smart coil.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was broken on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 101.0 and 138.0 cm from the proximal end.The pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.The embolization coil was intact with its pusher assembly.During functional testing, resistance was encountered while attempting to advance the pusher assembly¿s kink through its introducer sheath and the smart coil could not be advanced any further.Conclusions: evaluation of the first returned smart coil revealed that the embolization coil had offset coil winds.If the introducer sheath is not properly aligned within the hub of the microcatheter prior to advancement, resistance may be encountered and damage such as offset coil winds may occur.Further evaluation of the returned smart coil revealed kinks and a fracture on the pusher assembly.These damages may have occurred due to forcefully manipulation against resistance during the procedure, and some kinks may have occurred while packaging the device for return.Evaluation of the second returned smart coil revealed that the pusher assembly mid-joint was proximal to the introducer sheath friction lock.If the pusher assembly mid-joint is proximal to the introducer sheath friction lock, resistance may be encountered upon advancement, and the smart coil may not advance within its introducer sheath.If the device is forcefully advanced against this resistance, damage such as a kink in the pusher assembly may result.Further evaluation of the second returned smart coil revealed that the pet lock was broken on the proximal end of the pusher assembly.This damage was likely incidental to the reported 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: 1.3005168196-2020-00391.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: 9850907
• Report Number: 3005168196-2020-00392
• Device Sequence Number: 742972
• Product Code: HCG
• UDI-Device Identifier: 00814548015705
• UDI-Public: 00814548015705
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K143218
• 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): 02/24/2020
• 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: 06/03/2023
• Device Model Number: 400SMTHXSFT0203
• Device Catalogue Number: 400SMTHXSFT0203
• Device Lot Number: F83785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 05/04/2020
• 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