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

Catalog Number	400SMTHXSFT1H04
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2019
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 lumbar artery using penumbra smart coils (smart coils).During the procedure, the physician successfully placed eight smart coils using a non-penumbra microcatheter.While attempting to advance another smart coil within its introducer sheath, the physician felt resistance and was unable to advance the smart coil, consequently, the pusher assembly became kinked.Therefore, the smart coil was removed, and the procedure was completed using new smart coils.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 was kinked approximately 12.0 cm, 33.5 cm, 72.0 cm, 133.0 cm, 137.5 cm, 139.0 cm, 146.5 cm and 147.0 cm from the proximal end.The pusher assembly mid-joint was proximal to the introducer sheath friction lock.The embolization coil was intact with the pusher assembly distal detachment tip (ddt).The embolization coil had minor offset coil winds.Conclusions: evaluation of the returned smart coil confirmed a kinked pusher assembly and offset coil winds.If the introducer sheath is not properly aligned within the hub of its parent catheter, resistance may be experienced during advancement.If the device is further advanced against resistance, damage such as offset coil winds may occur.Further evaluation of the returned smart coil revealed that the pusher assembly was kinked.If the device is forcefully advanced against resistance, the pusher assembly may become kinked.The resistance from the offset coil winds likely contributed the pusher assembly kink.The non-penumbra microcatheter was not returned for evaluation.During functional testing, the smart coil was unable to advance out of its introducer sheath due to the kink near the mid-joint.Therefore, the introducer sheath was removed distally.While re-sheathing the smart coil, the kink near the mid-joint worsen into a fracture.Further evaluation revealed additional kinks along the pusher assembly.These kinks were 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: 8458273
• Report Number: 3005168196-2019-00575
• Device Sequence Number: 16908357
• Product Code: HCG
• UDI-Device Identifier: 00814548015675
• UDI-Public: 00814548015675
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 02/27/2019
• 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: 04/22/2023
• Device Catalogue Number: 400SMTHXSFT1H04
• Device Lot Number: F82976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 05/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Date Report Sent to FDA: 01/01/2005