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

Model Number	400SMTXSFT2H06
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 1.3005168196-2020-00577.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the posterior communicating artery (pcom) using penumbra smart coils (smart coils).During the procedure, a smart coil would not advance at all within its introducer sheath after several attempts and, therefore, it was removed.The physician then attempted to advance another smart coil; however, the same issue occurred.Therefore, the smart coil was removed.The procedure was completed using other coils.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 pusher assembly was kinked in multiple locations throughout its length.The embolization coil was knotted outside the distal tip of the introducer sheath.Conclusions: evaluation of the first returned smart coil revealed offset coil winds on the proximal end of the embolization coil.If the introducer sheath is not aligned within the hub a parent catheter, the embolization coil may begin to take shape within the hub and resistance may be experienced while advancing.Forceful advancement against resistance may result in offset coil winds.During functional testing, resistance was experienced while advancing the smart coil through its introducer sheath due to the offset coil winds and the coil was unable to advance at all.Evaluation of the second returned smart coil revealed that the embolization coil had offset coil winds and was knotted on its proximal end.If the introducer sheath is not aligned within the hub a parent catheter, the embolization coil may begin to take shape within the hub and resistance may be experienced while advancing.Forceful advancement against resistance may result in offset coil winds.The smart coil was unable to be re-sheathed during functional testing and could therefore not be functionally tested.The embolization coil becoming knotted likely occurred after removal from the procedure.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.This report is associated with mfr report number: 1.3005168196-2020-00577.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9988515
• Report Number: 3005168196-2020-00578
• Device Sequence Number: 4597788
• Product Code: HCG
• UDI-Device Identifier: 00814548015330
• UDI-Public: 00814548015330
• 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): 04/01/2020
• 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: 05/14/2023
• Device Model Number: 400SMTXSFT2H06
• Device Catalogue Number: 400SMTXSFT2H06
• Device Lot Number: F83436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/01/2020
• Supplement Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 06/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Date Report Sent to FDA: 01/01/2005