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

Model Number	400SMTHXSFT1H02
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2021
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 vertebral artery using penumbra smart coils (smart coils), a non-penumbra microcatheter, and a non-penumbra catheter.It should be noted that the patient's anatomy was tortuous, calcified, and narrowed.During the procedure, one smart coil was successfully implanted into the target location.While advancing the next smart coil in the microcatheter hub, resistance was encountered.It was reported that the distal tip of the smart coil was stuck in the gap between the microcatheter hub and the coil sheath.Therefore, the smart coil was removed from the procedure.The procedure was completed using another smart coil of the same size and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned smart coil revealed offset coil winds on the proximal end of the embolization coil.If the introducer sheath is not properly aligned within the hub of the microcatheter prior to advancement, resistance maybe encountered.Forceful advancement against this resistance may result in offset coil winds.During the functional test, resistance was encountered due to the offset coil winds on the proximal end of the embolization coil while attempting to advance the returned smart coil through the hub of a demonstration microcatheter, and the smart coil could not be advanced any further.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.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: 11867070
• Report Number: 3005168196-2021-01130
• Device Sequence Number: 3663367
• Product Code: HCG
• UDI-Device Identifier: 00814548015651
• UDI-Public: 00814548015651
• 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): 04/29/2021
• 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: 01/11/2022
• Device Model Number: 400SMTHXSFT1H02
• Device Catalogue Number: 400SMTHXSFT1H02
• Device Lot Number: F73738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 06/15/2021
• 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