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

Model Number	400SMTSFT0306
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/17/2020
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using a penumbra smart coil (smart coil).During the procedure, the smart coil kinked; therefore, the smart coil was removed.The procedure was completed using another smart coil.There was on report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (acom) using penumbra smart coils (smart coils).During the procedure, the physician placed two smart coils into the target location.It was reported that while attempting to remove a smart coil from its packaging, the smart coil kinked.Therefore, the smart coil was not used.The procedure was completed using another smart coil.There was on report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra sales representative on (b)(6)2020 : 1.Section b.Box 5.Describe event or problem it was previously understood that the kink occurred while in use in the patient.However, based on the updated information, the kink occurred during removal from the packaging prior to use in the patient.Note: although the event summary alleged a deterioration in the characteristics or performance of the device, this event did not and, it it were to recur, it would not cause or contribute to serious deterioration or death.Therefore, this is not considered a reportable event.The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.H3 other text : placeholder.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra sales representative on 08/23/2020: it was previously understood that the kink occurred during removal from the packaging prior to use in the patient.However, based on the updated information, the kink occurred while attempting to advance the smart coil on the back table, and would not exit its introducer sheath.Note: although the event summary alleged a deterioration in the characteristics or performance of the device, this event did not and, if it were to recur, it would not cause or contribute to serious deterioration or death.Therefore, this is not considered a reportable event.Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 138.0 cm from the proximal end.The pusher assembly mid-joint was retracted proximal to the introducer sheath frictional lock.The embolization coil was intact with the pusher assembly and undamaged.Conclusions: evaluation of the returned smart coil confirmed a pusher assembly kink.Further evaluation of the device revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If this occurs, resistance will likely be experienced while advancing the device.Forcefully advancing the device against this resistance may result in a pusher assembly kink.During functional testing, the smart coil was unable to advance at all from its returned position due to the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock; therefore, the smart coil was retracted from the introducer sheath and re-sheathed properly.Then the device was able to advance through its introducer sheath and a demonstration microcatheter with resistance due to the kink on the pusher assembly.Penumbra coils are visually 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (acom) using penumbra smart coils (smart coils).During the procedure, the physician placed two smart coils into the target location.While attempting to advance the next smart coil on the back table, the smart coil would not exit its introducer sheath and subsequently, the pusher assembly became kinked.Therefore, the smart coil was not used.The procedure was completed using another smart coil.There was on 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: 10273866
• Report Number: 3005168196-2020-00935
• Device Sequence Number: 14295662
• Product Code: HCG
• UDI-Device Identifier: 00814548015040
• UDI-Public: 00814548015040
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2020
• 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: 03/12/2025
• Device Model Number: 400SMTSFT0306
• Device Catalogue Number: 400SMTSFT0306
• Device Lot Number: F96958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 07/20/2020; 08/23/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 08/14/2020; 09/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Date Report Sent to FDA: 01/01/2005