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

Model Number	400SMTXSFT0410
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	10/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 85.0 and 102.0 cm from the proximal end.The pusher assembly mid-joint was retracted through the introducer sheath friction lock, and the friction lock was damaged.The embolization coil was undamaged and intact with the pusher assembly.Dried blood was present on the embolization coil and within the introducer sheaths distal tip.Conclusions: evaluation of the returned smart coil could not confirm the reported complaint.Further evaluation revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.This damage was likely incidental to the reported complaint and may have occurred after removal of the device from the procedure.During functional testing, the pusher assembly mid-joint was advanced through the introducer sheath friction lock with resistance.The embolization coil was then advanced out of the introducer sheath distal tip without an issue.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the hepatic artery using penumbra smart coils (smart coils), non-penumbra coils, a non-penumbra microcatheter, and non-penumbra angio-catheter.It was reported that the patient anatomy was tortuous, calcified, and narrowed.During the procedure, the physician implanted two smart coils and two other coils in the target vessel.While advancing the smart coil within the introducer sheath, the physician experienced resistance, and the smart coil became stuck at the distal tip of the introducer sheath.Therefore, the smart coil was removed.The procedure was completed using eight new smart coils, three non-penumbra coils, and the same microcatheter.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10870254
• Report Number: 3005168196-2020-02038
• Device Sequence Number: 19634240
• Product Code: HCG
• UDI-Device Identifier: 00814548015408
• UDI-Public: 00814548015408
• 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
• Report Date (Section B): 10/26/2020
• 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: 06/13/2022
• Device Model Number: 400SMTXSFT0410
• Device Catalogue Number: 400SMTXSFT0410
• Device Lot Number: F77669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• 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: 10/26/2020
• Initial Report FDA Received Date: 11/19/2020
• 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