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

Model Number	400SMTSFT0408
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2020
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), non-penumbra coils, and two non-penumbra microcatheters.During the procedure, the physician implanted a smart coil in the target vessel using the first microcatheter and two other coils using the other microcatheter.While advancing the next smart coil through the proximal end of the first microcatheter, the pusher assembly tip of the smart coil suddenly became stuck.Therefore, the microcatheter containing the stuck smart coil was removed.The procedure was completed using three non-penumbra coils and the second microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was separated on the proximal end of the pusher assembly.The pusher assembly was stuck inside the hub of the non-penumbra catheter.Unknown substances were observed within the hub of the non-penumbra catheter.Conclusions: evaluation of the returned smart coil pusher assembly confirmed that the pusher assembly was stuck and unable to be retracted from the non-penumbra catheter.Further evaluation revealed an unknown substance inside the hub of the non-penumbra catheter.This unknown substance likely contributed to the device becoming stuck within the catheter during the procedure.Further evaluation of the device also revealed that the pet lock was separated.This damage was likely incidental to the complaint.Based on the complaint, the embolization coil was implanted without issue.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.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #02 mfr report:3005168196-2020-01375 1.Section b.Box 5.Describe event or problem.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) using penumbra smart coils (smart coils), non-penumbra coils, and non-penumbra microcatheters.During the procedure, the physician implanted a smart coil in the target vessel using the first microcatheter and two other coils using the second microcatheter.While retracting the pusher assembly of the implanted smart coil through the proximal end of the phenom, the pusher assembly tip suddenly became stuck.Therefore, the first microcatheter containing the stuck pusher assembly was removed.The procedure was completed using three non-penumbra coils and the same second microcatheter.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10491773
• Report Number: 3005168196-2020-01375
• Device Sequence Number: 14184328
• Product Code: HCG
• UDI-Device Identifier: 00814548015088
• UDI-Public: 00814548015088
• 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,Followup
• Report Date (Section B): 08/12/2020
• 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: 07/10/2022
• Device Model Number: 400SMTSFT0408
• Device Catalogue Number: 400SMTSFT0408
• Device Lot Number: F78092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 09/11/2020; 01/14/2005
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 10/06/2020; 01/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Date Report Sent to FDA: 01/01/2005