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

Model Number	400SMTXSFT1H03
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2020
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils).During the procedure, the smart coil would not advance within its introducer sheath; therefore, it was removed.The procedure was completed using a new smart coil.There was no report of an adverse effect tot the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of its pusher assembly.The pusher assembly was kinked approximately 39.0 and 102.0 cm from its proximal end.The pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.The embolization coil was undamaged and intact with its pusher assembly.Conclusions: evaluation of the returned smart coil revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If this occurs, resistance maybe encountered during advancement, and the smart coil may not advance within its introducer sheath at all.During the functional test, the smart coil was able to be advanced out of its introducer sheath and through a demonstration microcatheter with initial resistance while advancing the pusher assembly mid-joint through the introducer sheath friction lock.Further evaluation revealed pusher assembly kinks.These kinks were likely incidental to the reported 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.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9707576
• Report Number: 3005168196-2020-00184
• Device Sequence Number: 3603089
• Product Code: HCG
• UDI-Device Identifier: 00814548015231
• UDI-Public: 00814548015231
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• 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): 01/21/2020
• 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: 06/21/2023
• Device Model Number: 400SMTXSFT1H03
• Device Catalogue Number: 400SMTXSFT1H03
• Device Lot Number: F84236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 02/13/2020
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Date Report Sent to FDA: 01/01/2005