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

Model Number	400SMTHXSFT1H03
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2020
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the testicular artery using penumbra smart coils (smart coils) and a non-penumbra microcatheter.It was noted that the patient anatomy was slightly tortuous, calcified and narrowed.During the procedure, the physician placed four smart coils in the target vessel using the microcatheter.Then, while advancing the next smart coil out of its introducer sheath, the physician experienced resistance and subsequently, the smart coil became stuck within the hub of the microcatheter.Therefore, the smart coil was removed.The procedure was completed using two smart coils, two non-penumbra coils and the same microcatheter.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 embolization coil was intact with the pusher assembly and had offset coil winds.Conclusions: evaluation of the returned smart coil revealed offset coil winds on the distal 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, and damage such as offset coil winds may occur.The offset coil winds may prevent the smart coil from advancing any further.During the functional test, the returned smart coil was advanced through a demonstration microcatheter without an issue.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.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10215622
• Report Number: 3005168196-2020-00852
• Device Sequence Number: 11404284
• Product Code: HCG
• UDI-Device Identifier: 00814548015668
• UDI-Public: 00814548015668
• 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): 06/10/2020
• 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: 07/24/2023
• Device Model Number: 400SMTHXSFT1H03
• Device Catalogue Number: 400SMTHXSFT1H03
• Device Lot Number: F84866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 07/28/2020
• 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