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

Model Number	400SMTSFT0515
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2019
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: 3005168196-2020-00020.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the posterior communicating artery (pcom) using penumbra smart coils, a penumbra smart coil detachment handle (handle) and a non-penumbra microcatheter.During the procedure, the physician advanced the smart coil in the target vessel using the microcatheter and attempted to detach it using the handle; however, the smart coil failed to detach.The physician then attempted to manually detach the smart coil; however, it would not detach.Therefore, the physician cut the pusher assembly near the rotating hemostasis valve (rhv) and the smart coil successfully detached.The procedure was completed at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was present on the hypotube but not on the pull tube on the proximal end of the pusher assembly.Kinks were present throughout the length of the pusher assemble.The pusher assembly was fractured approximately 16.0 and 175.0 cm from the proximal end.The distal detachment tip (ddt) was not returned for evaluation.The braided shaft was undamaged.Conclusions: evaluation of the returned smart coil pusher assembly revealed kinks and fractures.One of the two fractures was admitted to have occurred during the procedure in an attempt to detach the embolization coil.The additional fracture and kinks were likely incidental to the reported complaint and may have occurred post procedure.Based on the return condition, the root cause of the failure to detach could not be determined.Evaluation of the returned handle revealed an undamaged, functional device.The handle was tested on a handle test fixture and performed within specification.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.Penumbra handles are 100% visually inspected and functionally tested during incoming quality inspection.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: 3005168196-2020-00020.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9572259
• Report Number: 3005168196-2020-00019
• Device Sequence Number: 16632682
• Product Code: HCG
• UDI-Device Identifier: 00814548014944
• UDI-Public: 00814548014944
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2019
• 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: 04/09/2024
• Device Model Number: 400SMTSFT0515
• Device Catalogue Number: 400SMTSFT0515
• Device Lot Number: F89514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005