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

Catalog Number	400SMTXSFT3H06
Medical Device Problem Codes	Difficult to Advance (2920); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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 an embolization procedure in the posterior communicating artery (pcom) using a penumbra smart coil (smart coil).During the procedure, the physician placed a smart coil in the target vessel and while detaching, the smart coil retracted a bit.The physician attempted to re-insert the smart coil and experienced difficulty in pushing it in.The physician then attempted to insert the smart coil using the pusher assembly and it would not go in further.The physician decided to use a non-penumbra guide wire that is radiopaque at the tip, and slight resistance was experienced.It was reported that the physician felt like there was something between the smart coil and the guide wire, and the segment between the smart coil and the guide wire was not radiolucent.At this point, the physician managed to push the smart coil, but did not know where the non-radiolucent fragment was.This occurred after releasing the smart coil and the physician ended the procedure.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: 8777297
• Report Number: 3005168196-2019-01331
• Device Sequence Number: 11260916
• Product Code: HCG
• UDI-Device Identifier: 00814548017112
• UDI-Public: 00814548017112
• Combination Product (Y/N): Y
• Initial Reporter Country: EC
• 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): 06/10/2019
• 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: 04/19/2023
• Device Catalogue Number: 400SMTXSFT3H06
• Device Lot Number: F82944
• Was Device Available for Evaluation?: No
• 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: 06/10/2019
• Initial Report FDA Received Date: 07/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Date Report Sent to FDA: 01/01/2005