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

Model Number	400SMTSFT3H08
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2019
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: 3005168196-2019-02148.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (acom) using a penumbra smart coil (smart coil) and a penumbra smart coil detachment handle (handle).During the procedure, the physician coaxially advanced two non-penumbra microcatheters in the target vessel, then advanced the smart coil into the target vessel to frame the aneurysm.It was reported that the physician did not detach the smart coil.Next, the physician implanted four non-penumbra coils in the aneurysm, then attempted to detach the smart coil using the handle; however, the smart coil failed to detach.The physician then made two attempts to manually detach the smart coil, but these also failed.A final attempt was made to detach the smart coil using a mosquito forceps and the smart coil was successfully detached and implanted into the target vessel.The procedure was completed using four other coils.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 its pusher assembly.The pusher assembly was kinked approximately 2.0 cm from its proximal end.The pusher assembly was fractured approximately 1.5 cm from the proximal end.The embolization coil was detached from its pusher assembly and was not returned for evaluation.The braided section on the distal section of the pusher assembly was exposed.Conclusions: evaluation of the returned smart coil revealed that the pet lock was broken and the embolization coil was detached.Further evaluation of the returned smart coil revealed that the pusher assembly was kinked/fractured on the proximal end.This damage is likely a result of the multiple attempts to manually detach the embolization coil.Further evaluation revealed the braided shaft was exposed on the distal end of the pusher assembly.The root cause of this damage could not be determined but may have contributed to the difficulty detaching.Evaluation of the returned handle revealed a functional device.The handle was functionally tested on the handle fixture and passed within specification.No other devices associated with the complaint was returned for evaluation.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.Penumbra handles are visually inspected and functionally tested during incoming inspection by quality.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: 3005168196-2019-02148.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: 9329136
• Report Number: 3005168196-2019-02147
• Device Sequence Number: 2498711
• Product Code: HCG
• UDI-Device Identifier: 00814548017013
• UDI-Public: 00814548017013
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2019
• 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: 12/04/2021
• Device Model Number: 400SMTSFT3H08
• Device Catalogue Number: 400SMTSFT3H08
• Device Lot Number: F73016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/24/2019
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 02/04/2020
• 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