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

Model Number	400SMTXSFT0308
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/29/2020
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.This report is associated with mfr report number: 3005168196-2020-01066.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a dural arteriovenous fistula using penumbra smart coils (smart coils), a penumbra smart coil detachment handle (handle), and a non-penumbra microcatheter.It was noted that the patient's anatomy was tortuous.During the procedure, the physician implanted fifteen non-penumbra coils in the target location.While advancing the next smart coil, resistance was encountered, and the physician was only able to advance the smart coil a short distance past the introducer sheath.Therefore, the smart coil was removed.Next, a total of fourteen smart coils and non-penumbra coils were implanted in the target location and the handle was used to detach the smart coils.The physician attempted to implant a smart coil as the thirtieth coil; however, the handle would unable to detach the smart coil.It was also noted that the physician did not hear the "click" sound when depressing the handle.Therefore, the handle was removed.The procedure was completed by using a new handle to detach the same smart coil and a total of thirty-four additional smart coils and non-penumbra coils.It was also reported that after the procedure the handle was dropped on the floor.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 137.0 cm from its proximal end.The embolization coil was intact with its pusher assembly.The pusher assembly mid-joint was proximal to the introducer sheath friction lock.The outer diameter (od) of the pusher assembly mid-joint could not be measured due to the kink in the pusher assembly.The inner diameter (id) of the introducer sheath was measured within specification.Conclusions: evaluation of the returned smart coil revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If this occurs, resistance will likely be experienced while advancing the device.Further evaluation revealed a pusher assembly kink.This kink was likely a result of mishandling while advancing the device against resistance.During functional testing, the smart coil was unable to be advanced from its returned position within its introducer sheath; therefore, the smart coil pusher assembly was retracted from its introducer sheath and attempted to be re-sheathed properly; however, the introducer sheath could not be advanced over the kink in the pusher assembly.Therefore, the smart coil could not be functionally tested.Evaluation of the returned handle revealed that one of the tabs that holds the nosecone on the handle body was fractured off.This damage was likely a result of being dropped as reported in the complaint.Due to the returned condition, the root cause of the reported detachment issue could not be determined as the nose cone could not be reattached to the handle body and the device could therefore not be functionally tested.A clicking sound was heard when the handle was actuated during functional testing.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.Penumbra handles are 100% 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: 3005168196-2020-01066.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10348536
• Report Number: 3005168196-2020-01065
• Device Sequence Number: 2624418
• Product Code: HCG
• UDI-Device Identifier: 00814548015361
• UDI-Public: 00814548015361
• 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): 07/05/2020
• 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: 10/14/2023
• Device Model Number: 400SMTXSFT0308
• Device Catalogue Number: 400SMTXSFT0308
• Device Lot Number: F86442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/05/2020
• Supplement Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 07/31/2020
• 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
• Patient Age: 40 YR
• Date Report Sent to FDA: 01/01/2005