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

Model Number	400SMTXSFT0202
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2021
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 numbers: 3005168196-2021-00202, 3005168196-2021-00204, 3005168196-2021-00205.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the middle cerebral artery (mca) using penumbra smart coils (smart coils).During the procedure, four smart coils would not advance at all within their introducer sheaths; therefore, the four smart coils were removed.The procedure was completed using additional smart coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned first smart coil revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If this occurs, resistance will likely be experienced while advancing the device.Forcefully advancing the device against this resistance may have contributed to the kink and fracture which were observed near the pusher assembly mid-joint.Further evaluation of the device revealed an additional pusher assembly kink and a detached embolization coil.This damage was likely incidental to the complaint.Evaluation of the returned second smart coil revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If this occurs, resistance will likely be experienced while advancing the device.Forcefully advancing the device against this resistance may have contributed to the fractures which were observed near the pusher assembly mid-joint.Further evaluation of the device revealed a pusher assembly kink and a detached embolization coil.This damage was likely incidental to the complaint.Evaluation of the returned smart coil revealed offset coil winds along the length of its embolization coil and the embolization coil was returned partially advanced distal to the introducer sheath.Based on the returned condition, the reported complaint that the coil could not be advanced at all within its introducer sheath could not be confirmed.If the introducer sheath is not properly aligned within the hub of the microcatheter prior to advancement, resistance maybe encountered and damages such as offset coil winds may occur.During functional testing, the smart coil was unable to advance from its returned position due to the dried blood inside its introducer sheath.The dried blood inside the introducer sheath was likely incidental to the complaint.Further evaluation of the device revealed kinks along the pusher assembly.This damage was likely incidental to the complaint.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.This report is associated with mfr report numbers: 1.3005168196-2021-00202, 2.3005168196-2021-00204, 3.3005168196-2021-00205.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
• MDR Report Key: 11264398
• Report Number: 3005168196-2021-00203
• Device Sequence Number: 19123998
• Product Code: HCG
• UDI-Device Identifier: 00814548015262
• UDI-Public: 00814548015262
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 01/06/2021
• 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: 06/01/2025
• Device Model Number: 400SMTXSFT0202
• Device Catalogue Number: 400SMTXSFT0202
• Device Lot Number: F98178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005