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

Model Number	400SMTXSFT2H06
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	10/02/2020
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: 3005168196-2020-01844.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the major aortopulmonary collateral artery using penumbra smart coils (smart coils) and a non-penumbra microcatheter.During the procedure, the physician placed six smart coils into the target vessel using the microcatheter.While attempting to advance the next smart coil, the smart coil became stuck within its introducer sheath and would not advance at all from its initial position.Therefore, the smart coil was removed.The physician then placed six additional smart coils into the target vessel using the microcatheter.Afterwards, while the next smart coil was advanced through the middle of the microcatheter, the physician confirmed a deviation in the microcatheter tip position.Therefore, the smart coil was retracted into its introducer sheath.Then, while attempting to re-advance the same smart coil into the microcatheter, the distal tip of the smart coil became stuck when it reached the hub of the microcatheter.Therefore, the smart coil was removed.The procedure was completed using two additional smart 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.Bends were present throughout the length of the pusher assembly.The pusher assembly was kinked approximately 127.0 and 128.5 cm from the proximal end.The pusher assembly mid-joint was retracted into the introducer sheath friction lock.The embolization coil was intact with the pusher assembly and had offset coil winds.The non-penumbra microcatheter was ovalized approximately 149.0 cm from the hub.Conclusions: evaluation of the first returned smart coil revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.During functional testing, the pusher assembly mid-joint was advanced through the introducer sheath friction lock with strong resistance.The smart coil was then advanced through its introducer sheath without an issue.Evaluation of the second returned smart coil revealed offset coil winds on the embolization coil.If the device is forcefully advanced against resistance, damage such as this may occur.Further evaluation revealed pusher assembly kinks and the pusher assembly mid-joint was retracted through the introducer sheath friction lock.This damage was likely incidental to the reported complaint.Evaluation of the returned non-penumbra microcatheter revealed an ovalization on the distal shaft.The root cause of this damage could not be determined; however, this damage may have contributed to resistance while attempting to advance the second returned smart coil during the procedure.During functional testing, the second smart coil was advanced through the hub of the non-penumbra microcatheter without an issue; however, additional resistance was experienced due to the kink in the pusher assembly, and the smart coil could not advance any further.The first returned smart coil was advanced through the non-penumbra microcatheter without an issue.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: 3005168196-2020-01844.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10767139
• Report Number: 3005168196-2020-01845
• Device Sequence Number: 14330089
• Product Code: HCG
• UDI-Device Identifier: 00814548015330
• UDI-Public: 00814548015330
• 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): 10/05/2020
• 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: 08/16/2023
• Device Model Number: 400SMTXSFT2H06
• Device Catalogue Number: 400SMTXSFT2H06
• Device Lot Number: F85322
• 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: 10/05/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 10/31/2020
• Supplement Report FDA Received Date: 12/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 YR
• Date Report Sent to FDA: 01/01/2005