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

Model Number	400SMTSTD0725
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2021
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 numbers: 3005168196-2021-00314, 3005168196-2021-00315.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a neuro fistula using penumbra smart coils (smart coils) and a non-penumbra microcatheter.During the procedure, three smart coils would not advance within their introducer sheaths; therefore, the three smart coils were removed.The procedure was completed using additional smart coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned smart coil revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If this occurs, resistance will likely be experienced during advancement and the device may not be advanced out of the introducer sheath.During functional testing, the pusher assembly mid-joint was advanced through the introducer sheath friction lock with resistance.Then the smart coil was able to advance through the introducer sheath without issue.Further evaluation of the device revealed a pusher assembly kink.This damage was likely incidental to the complaint and may have occurred during packaging for return to penumbra.Evaluation of the returned smart coil revealed that the pusher assembly was kinked, and the embolization coil had offset coil winds.If the device is forcefully advanced against resistance, damage such as this may occur.The root cause of the resistance could not be determined.During functional testing, the smart coil was able to advance through the introducer sheath without issue.Evaluation of the returned smart coil revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If this occurs, resistance will likely be experienced during advancement and the device may not be advanced out of the introducer sheath.Forceful advancement against this resistance may have contributed to the kinks and fracture which were observed near the pusher assembly mid-joint.Further evaluation of the device revealed an additional pusher assembly kink.This damage was likely incidental to the complaint and may have occurred during packaging for return to penumbra.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: 1.3005168196-2021-00314.2.3005168196-2021-00315.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11360011
• Report Number: 3005168196-2021-00316
• Device Sequence Number: 3343507
• Product Code: HCG
• UDI-Device Identifier: 00814548014555
• UDI-Public: 00814548014555
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2021
• 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: 05/18/2024
• Device Model Number: 400SMTSTD0725
• Device Catalogue Number: 400SMTSTD0725
• Device Lot Number: F90411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 02/22/2021
• Supplement Report FDA Received Date: 05/26/2021
• 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