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

Model Number	400SMTHXSFT0308
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	10/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked throughout its length.The embolization coil was intact with the pusher assembly and had offset coil winds.The introducer sheath was not returned with the device for evaluation.Conclusions: evaluation of the returned smart coil revealed that the device was returned unsheathed and its introducer sheath was not returned for evaluation.Therefore, the reported complaint could not be confirmed.Further evaluation of the device revealed offset coil winds along the length of the embolization coil and kinks throughout its pusher assembly.This damage was likely incidental to the complaint and may have occurred during packaging for the device return.Functional testing was unable to be performed due to the kinks on the pusher assembly.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.(b)(4).
Event or Problem Description
The patient was a coil embolization in the posterior communicating artery (pcom) using penumbra smart coils (smart coils) and a non-penumbra microcatheter.During the procedure, a smart coil was stuck at the starting position of the introducer sheath.Therefore, the smart coil was removed.It was reported that the friction lock of the smart coil appeared to be tight.The procedure was completed using a new smart coil and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report:3005168196-2020-01902.Section g.Box 3.Report source.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10797628
• Report Number: 3005168196-2020-01902
• Device Sequence Number: 3799795
• Product Code: HCG
• UDI-Device Identifier: 00814548015798
• UDI-Public: 00814548015798
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2020
• 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: 09/23/2023
• Device Model Number: 400SMTHXSFT0308
• Device Catalogue Number: 400SMTHXSFT0308
• Device Lot Number: F86044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/11/2020
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 137
• Date Report Sent to FDA: 01/01/2005