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

Model Number	400SMTSFT0510
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2021
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: 3005168196-2021-00364.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (aca) using penumbra smart coils (smart coils), a penumbra smart coil detachment handle (handle), a non-penumbra microcatheter, and two non-penumbra guide catheters.It was noted that the patient anatomy was tortuous and calcified.During the procedure, the physician deployed and detached one smart coil in the target vessel using the microcatheter.The physician then advanced another smart coil into the target vessel and used the handle to detach it.However, the smart coil failed to detach.The physician made an additional attempt; however, the smart coil did not detach.Subsequently, the physician decided to remove the smart coil.Upon removal, the smart coil detached inside the microcatheter.Therefore, the microcatheter containing the detached smart coil was removed.The procedure was completed using three smart coils, a new handle, three other coils, and the same microcatheter.It was also reported that scratch marks were found on the proximal end of the handle post-procedure.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned smart coil revealed that the pet lock was separated.If the pet lock is separated and the pull wire is retracted during successful actuation of a handle, the embolization coil will detach.Further evaluation of the device revealed kinks on the pusher assembly and offset coil winds on the embolization coil.The kinks on the pusher assembly were likely a result of forceful advancement against resistance during the procedure.The offset coil winds on the embolization coil were likely incidental to the complaint.Evaluation of the returned handle was unable to confirm the reported complaint.During functional testing, the handle was functional tested on the handle fixture and performed within specification.The handle was able to detach a demonstration smart coil without issue.Further evaluation revealed funnel hole damage.If a pusher assembly is forcefully manipulated inside the nose cone funnel, damage such as this may occur.The nose cone was still within specification and this damage was likely incidental to the reported event.Penumbra coils and handles are visually inspected and functionally tested during incoming 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: 3005168196-2021-00364.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: 11391144
• Report Number: 3005168196-2021-00363
• Device Sequence Number: 19124263
• Product Code: HCG
• UDI-Device Identifier: 00814548015101
• UDI-Public: 00814548015101
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2021
• 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: 04/28/2021
• Device Model Number: 400SMTSFT0510
• Device Catalogue Number: 400SMTSFT0510
• Device Lot Number: F69147
• 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: 02/01/2021
• Supplement Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 04/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Date Report Sent to FDA: 01/01/2005