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

Model Number	400SMTXSFT0203
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 1.3005168196-2021-01454.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the middle cerebral artery (mca) using penumbra smart coils (smart coil), a benchmark 6f 071 delivery catheter (benchmark), and a non-penumbra microcatheter.During the procedure, the physician placed a smart coil in the aneurysm and realized that the smart coil was undersized; therefore, it was removed for later use.However, when the smart coil was removed from the patient's body it was noticed that the pusher assembly of the smart coil was kinked.Next, while attempting to advance another smart coil, the pusher assembly of the smart coil would not advance beyond the hub of the microcatheter and was found to be bent; therefore, it was removed.The procedure was completed using new smart coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned smart coil confirmed kinks in the pusher assembly.If the device is forcefully mishandled during use, damage such as this may occur.Further evaluation of the device revealed additional kinks in the pusher assembly and offset coil winds along the length of the embolization coil.This damage was likely incidental to the complaint and may have occurred during packaging for the device return.The smart coil was returned without its introducer sheath.Evaluation of the returned smart coil confirmed a kink in the pusher assembly.If the device is forcefully mishandled at an extreme angle, during advancement, damage such as this may occur.This damage likely contributed to the resistance experienced while advancing the smart coil through the hub of the microcatheter.During functional testing, the smart coil was able to advance through the introducer sheath and a demonstration microcatheter with resistance due to the kink in the pusher assembly.Further evaluation of the device revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.This damage is likely incidental to the complaint.The manufacturing records for this lot were reviewed and did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 number: 3005168196-2021-01454.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12104557
• Report Number: 3005168196-2021-01453
• Device Sequence Number: 14450240
• Product Code: HCG
• UDI-Device Identifier: 00814548015279
• UDI-Public: 00814548015279
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2021
• 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: 10/24/2021
• Device Model Number: 400SMTXSFT0203
• Device Catalogue Number: 400SMTXSFT0203
• Device Lot Number: F72476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Date Report Sent to FDA: 01/01/2005