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

Model Number	400SMTXSFT0410
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2020
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: 3005168196-2020-02320.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a dural arteriovenous fistula (davf) using penumbra smart coils (smart coils) and a non-penumbra microcatheter.It was noted that the patient anatomy was moderately tortuous, calcified and narrowed.During the procedure, the physician placed two non-penumbra coils into the target location using the microcatheter.The physician then advanced a smart coil into the target location using the microcatheter.While forming the smart coil into the target location, the physician was not satisfied with how the smart coil was forming and decided to retract the smart coil to re-form it.While retracting the smart coil, the physician experienced resistance.Subsequently, the smart coil would not retract.Therefore, the physician removed the smart coil and microcatheter together and then removed the smart coil from the distal end of the microcatheter.Next, the microcatheter was flushed to confirm the patency using a guidewire.Afterwards, the physician placed four non-penumbra coils into the target location using the microcatheter.While attempting to advance another smart coil out of its introducer sheath, the physician experienced resistance and the smart coil became stuck within its introducer sheath.Subsequently, the pusher assembly of the smart coil kinked.Therefore, the smart coil was removed.The procedure was completed using seven other and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the first returned smart coil revealed offset coil winds along the embolization coil and the coil was knotted.If the device is manipulated against resistance, damage such as this may occur.This damage likely contributed to the inability to re-sheath the smart coil during the procedure and the functional test.Further evaluation revealed pusher assembly bends and kinks.This damage was likely incidental to the reported complaint.Evaluation of the second returned smart coil confirmed a pusher assembly kink.Further evaluation revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.If the smart coil is forcefully advanced against this resistance, damage such as pusher assembly kinks may occur.The smart coil was unable to be advanced out of its introducer sheath due to the pusher assembly kink.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.This report is associated with mfr report number: 1.3005168196-2020-02320 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: 11045427
• Report Number: 3005168196-2020-02319
• Device Sequence Number: 2691812
• Product Code: HCG
• UDI-Device Identifier: 00814548015408
• UDI-Public: 00814548015408
• 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): 11/26/2020
• 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: 04/22/2024
• Device Model Number: 400SMTXSFT0410
• Device Catalogue Number: 400SMTXSFT0410
• Device Lot Number: F89813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/26/2020
• Supplement Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 02/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Date Report Sent to FDA: 01/01/2005