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

Model Number	400SMTXSFT0104
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.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 external carotid artery using penumbra smart coils (smart coils) and a non-penumbra microcatheter.During the procedure, the smart coil was unable to advance past its initial position within its introducer sheath.Therefore, the smart coil was removed.The procedure was completed using another smart coil and the same microcatheter.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 proximal end of the introducer sheath friction lock was wrinkled.The embolization coil was intact with the pusher assembly.Offset coil winds were present along the embolization coil.Conclusions: evaluation of the returned smart coil revealed offset coil winds along the embolization coil.This indicates that the smart coil was able to be advanced from its initial position within its introducer sheath.If the introducer sheath is not aligned properly within the hub of a parent catheter, resistance may be experienced during advancement.If the device is forcefully advanced against this resistance, damage such as offset coil winds may occur.During functional testing, the smart coil was advanced through its introducer sheath with resistance due to the offset coil winds.While attempting to advance the smart coil through a demonstration microcatheter, resistance was experienced at the hub of the microcatheter due to the offset coil wind and the smart coil could not be advanced any further.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: 9922424
• Report Number: 3005168196-2020-00503
• Device Sequence Number: 3296152
• Product Code: HCG
• UDI-Device Identifier: 00814548015507
• UDI-Public: 00814548015507
• Combination Product (Y/N): Y
• Initial Reporter State: NV
• 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): 03/10/2020
• 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: 10/30/2021
• Device Model Number: 400SMTXSFT0104
• Device Catalogue Number: 400SMTXSFT0104
• Device Lot Number: F72557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 05/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 91
• Date Report Sent to FDA: 01/01/2005