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

Model Number	400SMTXSFT0206
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2021
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: 3005168196-2021-00949.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) using penumbra smart coils (smart coils).During the procedure, two smart coils would not advance from the starting position in their introducer sheaths.Therefore, they were removed.The procedure was completed using a new smart coil.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the first returned smart coil revealed the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.Forceful advancement against this resistance likely contributed to the pusher assembly kinks observed near the mid-joint.During functional testing, the pusher assembly mid-joint was only able to advance slightly from its returned position within the introducer sheath before additional resistance was experienced due to the pusher assembly kinks, and the smart coil could not be advanced any further.Evaluation of the second returned smart coil revealed the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.Further evaluation revealed pusher assembly kinks.This damage was likely incidental to the reported complaint.During functional testing, the smart coil was able to advance out of its introduce sheath with initial resistance while advancing the pusher assembly mid-joint through the introducer sheath friction lock, and then additional resistance due to the pusher assembly kinks.Penumbra coils are 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: 3005168196-2021-00949.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11773291
• Report Number: 3005168196-2021-00950
• Device Sequence Number: 3778597
• Product Code: HCG
• UDI-Device Identifier: 00814548016030
• UDI-Public: 00814548016030
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• 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): 04/07/2021
• 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: 05/21/2023
• Device Model Number: 400SMTXSFT0206
• Device Catalogue Number: 400SMTXSFT0206
• Device Lot Number: F83601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Date Report Sent to FDA: 01/01/2005