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

Model Number	400SMTXSFT0102
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
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: 3005168196-2021-01515.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the pericallosal artery using penumbra smart coils (smart coil), penumbra smart coil detachment handle (handle), and a non-penumbra microcatheter.During the procedure, the physician placed one smart coil in the target location using the microcatheter.Next, another smart coil was advanced in the target location and the physician attempted to detach it using the handle; however, the smart coil failed to detach.After attempting various methods to detach the smart coil, the physician was finally able to detach the smart coil.The same issue occurred with the next smart coil as well; however, the physician was able to detach the smart coil.The procedure was completed at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the first returned smart coil was unable to confirm the reported difficulty detaching.Evaluation revealed the embolization coil was detached, and the pet lock was broken.This is typically evidence of a successful detachment.Based on the returned condition, the root cause of the reported detachment issue could not be determined.Further evaluation of the returned smart coil revealed kinks throughout the pusher assembly.This damage was incidental to the reported complaint and may have occurred during packaging of the device for return.Evaluation of the second returned smart coil was unable to confirm the reported difficulty detaching.Evaluation revealed the embolization coil was detached and the pet lock was broken.This is typically evidence of a successful detachment.Based on the returned condition, the root cause of the reported detachment issue could not be determined.Further evaluation of the returned smart coil revealed a kink in the pusher assembly.This damage was incidental to the reported complaint and may have occurred during packaging of the device for return.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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the reported difficulty detaching this report is associated with mfr report number: 1.3005168196-2021-01515 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: 12154837
• Report Number: 3005168196-2021-01514
• Device Sequence Number: 11953322
• Product Code: HCG
• UDI-Device Identifier: 00814548015187
• UDI-Public: 00814548015187
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2021
• 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: 03/30/2026
• Device Model Number: 400SMTXSFT0102
• Device Catalogue Number: 400SMTXSFT0102
• Device Lot Number: F105056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 07/12/2021
• Supplement Report FDA Received Date: 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 83
• Date Report Sent to FDA: 01/01/2005