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

Model Number	400SMTHXSFT0208
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned smart coil revealed offset coil winds throughout the length of the embolization coil and pusher assembly kinks.The probable cause of the reported failure likely due to forceful handling against resistance.If the smart coil is forcefully manipulated against resistance during use, damage such as offset coil winds may occur.Further advancement against this resistance likely contributed the pusher assembly kink.The root cause of the initial resistance during the procedure could not be determined.During the functional test, resistance was encountered while attempting to re-sheath the returned smart coil with a demonstration introducer sheath due to the kink in the pusher assembly, and no further functional testing could be performed.Penumbra products 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 collateral branch of the posterior intercostal artery using penumbra smart coils (smart coils) and a non-penumbra microcatheter.During the procedure, four smart coils and ten non-penumbra coils were implanted into the target location.It was reported that the microcatheter was flushed each time a coil was inserted.While advancing the next smart coil through the middle of the microcatheter, it became stuck.Therefore, the smart coil was removed.The procedure was completed using seven additional smart coils, eleven other coils, and the same 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: 12602505
• Report Number: 3005168196-2021-02235
• Device Sequence Number: 11561580
• Product Code: HCG
• UDI-Device Identifier: 00814548015996
• UDI-Public: 00814548015996
• 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
• Report Date (Section B): 10/08/2021
• 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: 10/21/2025
• Device Model Number: 400SMTHXSFT0208
• Device Catalogue Number: 400SMTHXSFT0208
• Device Lot Number: F101412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 10/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 YR
• Patient Weight: 11
• Date Report Sent to FDA: 01/01/2005