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

Model Number	400SMTHXSFT0204
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2021
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 numbers: 3005168196-2021-01950, 3005168196-2021-01951, 3005168196-2021-01952, 3005168196-2021-01953, 3005168196-2021-01954.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the hepatic artery using penumbra smart coils (smart coils) and a non-penumbra microcatheter.It was noted that the patient anatomy was tortuous.During the procedure, the physician successfully placed three smart coils in the target location using the microcatheter.While advancing the next smart coil approximately a few centimeters into the microcatheter, the physician experienced resistance and subsequently, the smart coil became stuck past the hub of the microcatheter.Therefore, the smart coil was removed.Next, while advancing another smart coil approximately a few centimeters into the microcatheter, the same issue occurred.The physician experienced resistance and subsequently, the smart coil became stuck past the hub of the microcatheter.Therefore, the smart coil was also removed.Afterwards, the next three smart coils advanced slightly past their initial positions within their respective introducer sheaths before becoming stuck within their respective introducer sheaths.Therefore, the three smart coils were removed.It was also reported that the physician attempted to advance another smart coil to the target location; however, the physician was unable to advance the smart coil to the target location.Therefore, the smart coil was removed.The procedure was completed using a new smart coil, five non-penumbra 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 could not confirm the reported coil stuck within its introducer sheath.During functional testing, the smart coil was able to be advanced through its introducer sheath without an issue.Further evaluation of the device revealed offset coil winds along the length of the embolization coil.This damage likely occurred due to forceful advancement against resistance.If the introducer sheath is not properly aligned within the hub of a parent microcatheter prior to advancement, resistance may be encountered and damage such as offset coil winds may occur.During functional testing, the smart coil was unable to be advanced through the hub of the demonstration microcatheter due to the offset coil winds.Evaluation of the returned smart coil could not confirm the reported coil stuck within its introducer sheath.During functional testing, the smart coil was able to be advanced through its introducer sheath and a demonstration microcatheter without an issue.Further evaluation of the device revealed a kink in the pusher assembly.This kink was likely incidental to the complaint and may have occurred during packaging for return to penumbra.Evaluation of the returned smart coil revealed offset coil winds along the length of the embolization coil and kinks in the pusher assembly.This damage likely occurred due to forceful advancement against resistance.If the smart coil is advanced through the reported tortuous patient¿s anatomy, resistance may encounter and damage such as offset coil winds and pusher assembly kink may occur.During functional testing, the smart coil was able to be advanced through a demonstration introducer sheath without issue.The device was unable to be advanced through the hub of the demonstration microcatheter due to the offset coil winds.Further evaluation of the device revealed additional kinks in the pusher assembly.This damage was likely incidental to the complaint.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: 1.3005168196-2021-01950, 2.3005168196-2021-01951, 3.3005168196-2021-01952, 4.3005168196-2021-01953, 5.3005168196-2021-01954.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 12601971
• Report Number: 3005168196-2021-02230
• Device Sequence Number: 3193493
• Product Code: HCG
• UDI-Device Identifier: 00814548015712
• UDI-Public: 00814548015712
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2021
• 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: 11/03/2025
• Device Model Number: 400SMTHXSFT0204
• Device Catalogue Number: 400SMTHXSFT0204
• Device Lot Number: F101700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 10/09/2021
• Supplement Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/01/2005