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

Model Number	400SMTXSFT0102
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2021
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the superior mesenteric artery using penumbra smart coils (smart coil), a non-penumbra microcatheter, and non-penumbra coils.It was noted that the patient¿s anatomy was mildly tortuous.During the procedure, a smart coil would not advance at all past its initial position within its introducer sheath after the physician made several attempts; therefore, the smart coil was removed.The procedure was completed using two smart coils, three 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Evaluation of the returned smart coil revealed that the pusher assembly mid-joint was retracted through the proximal end of the introducer sheath, and the embolization coil had offset coil winds along its length.This indicates that the device was likely able to advance from its initial position; therefore, the reported complaint could not be confirmed.During functional testing, after flushing the rest of the smart coil out of the introducer sheath, the smart coil was re-sheathed without an issue.Subsequently, the smart coil was advanced through the introducer sheath with resistance due to the offset coil winds.The root cause of the offset coil winds could not be determined; however, this damage may have contributed to resistance during the procedure.Further evaluation revealed a pusher assembly kink.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.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12450358
• Report Number: 3005168196-2021-01991
• Device Sequence Number: 3516863
• 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): 09/21/2021
• 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: 11/01/2021
• Device Model Number: 400SMTXSFT0102
• Device Catalogue Number: 400SMTXSFT0102
• Device Lot Number: F72607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/18/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 09/21/2021
• 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