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

Model Number	400SMTHXSFT0102
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure using a penumbra smart coil (smart coil).During the procedure, the smart coil would not advance past its initial position within its introducer sheath.Therefore, the smart coil was removed.The procedure was completed using non-penumbra coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
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Evaluation of the returned smart coil revealed that the pusher assembly mid-joint was retracted through the proximal end of the introducer sheath.If this occurs, resistance will likely be experienced during advancement.Forceful advancement against this resistance likely contributed to the kinks and fracture observed near the mid-joint, and the friction lock missing from the introducer sheath.Further evaluation revealed additional pusher assembly kinks, pet lock damage on the proximal end of the pusher assembly, and offset coil winds on distal end of the embolization coil.This damage was likely incidental to the reported complaint and may have occurred during return to penumbra.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.H3 other text : placeholder.

• 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: 12782777
• Report Number: 3005168196-2021-02529
• Device Sequence Number: 12247761
• Product Code: HCG
• UDI-Device Identifier: 00814548015613
• UDI-Public: 00814548015613
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2022
• 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: 01/27/2026
• Device Model Number: 400SMTHXSFT0102
• Device Catalogue Number: 400SMTHXSFT0102
• Device Lot Number: F103556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• 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: 10/13/2021
• Supplement Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2021
• 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