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

Model Number	400SMTHXSFT0306
Medical Device Problem Code	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	10/20/2020
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the cerebral artery using penumbra smart coils (smart coil) and non-penumbra microcatheter.During the procedure, the physician placed a smart coil and ten other coils in the target vessel using a microcatheter.While attempting to advance another smart coil into the microcatheter, the smart coil became stuck at the distal tip of the introducer sheath and, therefore, the smart coil was removed.The procedure was completed using additional smart coils, other 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.The pusher assembly was kinked approximately 137.0 from the proximal end and was fractured approximately 138.5 cm from the proximal end.The pusher assembly mid-joint was retracted through the introducer sheath friction lock, and the friction lock was damaged.The embolization coil was undamaged and detached from the pusher assembly within the introducer sheath.Blood was within the introducer sheath distal tip.Conclusions: evaluation of the returned smart coil revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.Forceful advancement against this resistance likely contributed to the fracture observed near the pusher assembly mid-joint.Further evaluation revealed that the embolization coil was detached from the pusher assembly.This damage was likely a result of the pusher assembly fracture.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: 10844117
• Report Number: 3005168196-2020-02004
• Device Sequence Number: 19744015
• Product Code: HCG
• UDI-Device Identifier: 00814548015781
• UDI-Public: 00814548015781
• 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): 10/23/2020
• 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: 01/25/2025
• Device Model Number: 400SMTHXSFT0306
• Device Catalogue Number: 400SMTHXSFT0306
• Device Lot Number: F95786
• 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
• Initial Date Received by Manufacturer: 10/23/2020
• Supplement Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 11/18/2020
• 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