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

Model Number	400SMTXSFT2H03
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	09/24/2020
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: 3005168196-2020-01793.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coil) and non-penumbra microcatheter.During the procedure, the physician was unable to advance two smart coils through the microcatheter and, therefore, both smart coils was removed and saved for later use.The physician then exchanged for a new microcatheter and attempted to advance the same smart coils; however, the same issue occurred.Therefore, both smart coils were removed.The procedure was completed using other coils and the same 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 pusher assembly had kinks throughout its length.The embolization coil was intact with the pusher assembly and had offset coil winds throughout its length.Conclusions: evaluation of the first returned smart coil revealed offset coil winds throughout its embolization coil.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 unable to advance through the introducer sheath due to the offset coil winds on its embolization coil.Further evaluation of the device revealed kinks throughout the pusher assembly.This damage was likely incidental to the complaint and may have occurred during packaging for device return.Evaluation of the second returned smart coil revealed offset coil winds throughout its embolization coil.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 with resistance.The smart coil was unable to advance through a demonstration microcatheter due to the offset coil winds on its embolization coil.Further evaluation of the device revealed kinks throughout the pusher assembly and separated pet lock.This damage was likely incidental to the complaint and may have occurred during packaging for device return.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: 1.3005168196-2020-01793 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: 10708837
• Report Number: 3005168196-2020-01792
• Device Sequence Number: 3456997
• Product Code: HCG
• UDI-Device Identifier: 00814548015316
• UDI-Public: 00814548015316
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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): 09/25/2020
• 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: 04/15/2024
• Device Model Number: 400SMTXSFT2H03
• Device Catalogue Number: 400SMTXSFT2H03
• Device Lot Number: F89653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/25/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 12/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Date Report Sent to FDA: 01/01/2005