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

Model Number	400SMTXSFT1H03
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2020
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.This report is associated with mfr report number: 3005168196-2020-00356.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat an anterior communicating artery (acom) aneurysm using penumbra smart coils (smart coils) and a penumbra smart coil detachment handle (handle).During the procedure, the physician placed smart coils in the aneurysm using the handle and then advanced the next smart coil.Several attempts were made to detach it using the handle but was unsuccessful.The physician also attempted to use their fingers to manually detach the smart coil but was unsuccessful.Subsequently, the physician used a needle driver to successfully detach the coil.The procedure ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was broken on the proximal end of the pusher assembly.Kinks were present along the length of the pusher assembly.The pusher assembly and the pull wire were fractured approximately 15.0 cm from the proximal end.The pull wire was retracted from the distal detachment tip (ddt) and the embolization coil was detached and not returned for evaluation.The pusher assembly braided section was delaminated from approximately 170.0 cm to 180.0 cm from the proximal end.Conclusions: evaluation of the returned smart coil pusher assembly confirmed the detached coil.Further evaluation of the returned pusher assembly revealed that the pet lock was broken, the pusher assembly and pull wire were fractured.These damages likely occurred due to the manual detachment reported during the procedure.Further evaluation also revealed the braided section of the pusher assembly was delaminated.This damage may have contributed to the difficulty detaching experienced during the procedure.Based on the returned condition, the root cause of the braided shaft delamination could not be determined.Kinks on the pusher assembly were likely a result of improper handling during packaging for return to penumbra and were 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.This report is associated with mfr report number: 3005168196-2020-00356.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9831281
• Report Number: 3005168196-2020-00357
• Device Sequence Number: 740380
• Product Code: HCG
• UDI-Device Identifier: 00814548015231
• UDI-Public: 00814548015231
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2020
• 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: 10/20/2021
• Device Model Number: 400SMTXSFT1H03
• Device Catalogue Number: 400SMTXSFT1H03
• Device Lot Number: C17982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 04/10/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 04/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Date Report Sent to FDA: 01/01/2005