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

Catalog Number	400SMTXSFT0406
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2019
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Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.The embolization coil was undamaged and intact with the pusher assembly.The introducer sheath was ovalized at approximately 18.0 cm from its proximal end.Upon functional testing, resistance was experienced while attempting to advance the smart coil through its introducer sheath; therefore, the smart coil was retracted from its introducer sheath.The smart coil was then unable to be re-sheathed due to the ovalization on the introducer sheath.The smart coil introducer sheath was removed, and a demonstration introducer sheath was used instead.Then smart coil was able to advance through the demonstration introducer sheath and a demonstration microcatheter without an issue.Conclusions: evaluation of the returned smart coil revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If the mid-joint was retracted proximal to the introducer sheath friction lock, resistance may be encountered during advancement of the smart coil within its introducer sheath.Further investigation revealed an ovalization on the introducer sheath.This damage was likely incidental to the complaint.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left communicating segment of the intradural aneurysm using a penumbra smart coil (smart coil).During the procedure, the smart coil was unable to advance out of the introducer sheath; therefore, it was removed.The procedure was completed using additional coils.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: 9219636
• Report Number: 3005168196-2019-01978
• Device Sequence Number: 2223819
• Product Code: HCG
• UDI-Device Identifier: 00814548015385
• UDI-Public: 00814548015385
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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
• Report Date (Section B): 09/24/2019
• 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: 03/05/2024
• Device Catalogue Number: 400SMTXSFT0406
• Device Lot Number: F88914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• 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: 09/24/2019
• Initial Report FDA Received Date: 10/22/2019
• 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