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

Catalog Number	400SMTXSFT0104
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2018
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 in the internal carotid artery (ica) using penumbra smart coils (smart coils).During the procedure, the physician successfully placed coils into the target vessel using a non-penumbra microcatheter.The physician then attempted to advance a smart coil, however, the smart coil could not advance from its starting position within the introducer sheath.The smart coil was then removed and was not used in the procedure.The procedure was completed using additional coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact at the proximal end of the pusher assembly.The pusher assembly had bends and kinks approximately 6.0 cm, 19.0 cm, 22.0 cm, 56.0 cm, 91.0 and 126.0 cm from the proximal end.The mid-joint of the pusher assembly was advanced distal through the introducer sheath.The embolization coil had offset coil winds on its proximal end and was intact with the distal detachment tip (ddt) of the pusher assembly.Conclusions: evaluation of the returned smart coil revealed a device with offset coil winds.If the introducer sheath is not properly aligned within the hub prior to advancement, resistance may be experienced when attempting to advance the coil into the microcatheter.If the device is forcefully advanced against this resistance, some offset coil winds may result.This damage may contribute to additional resistance on subsequent attempts to advance.It also likely contributed to the difficulty advancing reported during the procedure and experienced during functional testing.Further evaluation revealed bends and kinks along the pusher assembly.These damages are likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.Penumbra coils are 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: 8238311
• Report Number: 3005168196-2019-00048
• Device Sequence Number: 13842435
• Product Code: HCG
• UDI-Device Identifier: 00814548015507
• UDI-Public: 00814548015507
• Combination Product (Y/N): Y
• Initial Reporter Country: PL
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2018
• 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: 06/22/2022
• Device Catalogue Number: 400SMTXSFT0104
• Device Lot Number: F77862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 03/01/2019
• 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
• Date Report Sent to FDA: 01/01/2005