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

Model Number	400SMTSFT0408
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2020
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) using penumbra smart coils (smart coils), a penumbra smart coil detachment handle (handle), and non-penumbra microcatheter.During the procedure, the physician advanced a smart coil to the target vessel using the microcatheter and made two attempts to detach the smart coil using the handle.However, the handle failed to detach the smart coil.Subsequently, a hemostat was used to manually detach the smart coil.The procedure was completed using another smart coil and the same handle.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was broken and separated on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 12.0 cm and 142.0 cm from the proximal end.The pull wire was retracted from the pusher assembly distal detachment tip (ddt) and the embolization coil was detached from the pusher assembly and not returned for evaluation.The pusher assembly braided section was delaminated from approximately 169.0 cm to 179.0 cm from the proximal end.Conclusions: evaluation of the returned smart coil pusher assembly confirmed that the embolization coil was detached from the pusher assembly and revealed that the pet lock was broken and separated.These damages likely occurred due to the reported manual detachment during the procedure.Further evaluation of the device revealed the braided section of the pusher assembly was delaminated and pusher assembly kinks.The root cause of the braided shaft delamination could not be determined; however, this damage may have contributed to the difficulty detaching experienced during the procedure.The kinks on the pusher assembly were likely incidental to the complaint and may have occurred during packaging for return to penumbra.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.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10345152
• Report Number: 3005168196-2020-01051
• Device Sequence Number: 824678
• Product Code: HCG
• UDI-Device Identifier: 00814548015088
• UDI-Public: 00814548015088
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2020
• 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: 06/21/2023
• Device Model Number: 400SMTSFT0408
• Device Catalogue Number: 400SMTSFT0408
• Device Lot Number: F84252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 08/23/2020
• 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