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

Model Number	400SMTXSFT0102
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	01/08/2021
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: 3005168196-2021-00220.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the lumbar artery using penumbra smart coils (smart coils) and a non-penumbra microcatheter.It should be noted that the patient's anatomy was tortuous.During the procedure, six smart coils were implanted into the target location without issue.After aligning the next smart coil introducer sheath with the microcatheter hub, the smart coil became stuck at the distal tip during advancement.Therefore, the smart coil was no longer used in the procedure.Next, the same issue occurred with another smart coil.Therefore, that smart coil was no longer used in the procedure.The procedure was completed using five additional smart coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the first returned smart coil revealed offset coil winds on the proximal end of the embolization coil.If the introducer sheath is not aligned properly within the hub of a parent microcatheter, resistance may be experienced during advancement and damage such as offset coil winds may occur.Further evaluation revealed that the pusher assembly mid-joint was retracted through the introducer sheath.During functional testing, the smart coil could not advance at all within its introducer sheath due to the offset coil winds; therefore, the introducer sheath was removed distally and attempted to be re-sheathed but was unsuccessful as an unknown substance was unable to be removed from the introducer sheath.The smart coil was re-sheathed with a demonstration introducer sheath and was unable to advance due to resistance caused by the offset coil winds on the embolization coil.Evaluation of the second returned smart coil revealed offset coil winds on the proximal end of the embolization coil.If the introducer sheath is not aligned properly within the hub of a parent microcatheter, resistance may be experienced during advancement and damage such as offset coil winds may occur.During functional testing, the smart coil could not advance at all within its introducer sheath due to the offset coil winds.Further evaluation revealed pusher assembly kinks.This damage was likely incidental to the reported complaint.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: 1.3005168196-2021-00220.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11283396
• Report Number: 3005168196-2021-00219
• Device Sequence Number: 14321544
• Product Code: HCG
• UDI-Device Identifier: 00814548015187
• UDI-Public: 00814548015187
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2021
• 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: 11/07/2021
• Device Model Number: 400SMTXSFT0102
• Device Catalogue Number: 400SMTXSFT0102
• Device Lot Number: F72692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 03/09/2021
• 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