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

Model Number	400SMTSFT0308
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2019
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 anterior communicating artery (acom) using penumbra smart coils (smart coils).During the procedure, a smart coil was stuck and would not advance from its starting position inside of the introducer sheath.Therefore, it was removed.The physician then attempted to advance a new smart coil into the non-penumbra microcatheter; however, a small particle was blocking the inner lumen of the microcatheter.Therefore, the microcatheter was removed and flushed to remove the small particle.The procedure was completed using the same smart coil and microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided a penumbra distributor on 18-dec-2019: section b.Box 5.Describe event or problem.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (acom) using penumbra smart coils (smart coils).During the procedure, the physician placed several smart coils in the target vessel using a non-penumbra microcatheter.While attempting to place another smart coil, it became stuck and would not advance from its starting position inside of the introducer sheath.Therefore, the smart coil was removed.The physician then attempted to advance a new smart coil into the microcatheter; however, a small particle was blocking the inner lumen of the microcatheter.Therefore, the microcatheter was removed and flushed to remove the small particle.The procedure was completed using the same smart coil, additional smart 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 on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 42.5, 45.5, 127.0 and 136.5 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.Offset coil winds were present on the distal end of the embolization coil.Approximately 11.0 cm of the braided shaft was exposed on the pusher assembly approximately 171.0 ¿ 182.0 cm from the proximal end.The unknown particle was returned with the smart coil.Conclusions: evaluation of the returned smart coil revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.Further evaluation revealed offset coil winds on the distal end of the embolization coil and a pusher assembly kink.The offset coil winds indicate that the smart coil was likely advanced out of its introducer sheath during the procedure.If the parent catheter is occluded or if the introducer sheath is not aligned properly within the hub of a parent catheter, resistance may be experienced during advancement and damage such as offset coil winds and pusher assembly kinks may occur.During functional testing, the smart coil was advanced through its introducer sheath and a demonstration microcatheter with resistance while advancing the pusher assembly mid-joint through the introducer sheath friction lock.The mid-joint being retracted proximal to the introducer sheath friction lock likely contributed to the resistance experienced during subsequent attempts to advance the smart coil during the procedure, and the functional test.Further evaluation revealed additional pusher assembly kinks and a damaged braided shaft.This damage was likely incidental to the reported complaint.The particle returned with the smart coil was unknown.Based on the reported complaint and the returned smart coil being completely intact, the whereabouts of this particulate could not be determined.This particulate may have contributed to the difficulty advancing experienced during the procedure.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: 9173471
• Report Number: 3005168196-2019-01916
• Device Sequence Number: 2402153
• Product Code: HCG
• UDI-Device Identifier: 00814548015057
• UDI-Public: 00814548015057
• Combination Product (Y/N): Y
• Initial Reporter Country: EC
• 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,Followup
• Report Date (Section B): 09/13/2019
• 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: 06/21/2023
• Device Model Number: 400SMTSFT0308
• Device Catalogue Number: 400SMTSFT0308
• Device Lot Number: F84250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/13/2019
• Supplement Date Received by Manufacturer: 01/15/2020; 01/14/2005
• Initial Report FDA Received Date: 10/09/2019
• Supplement Report FDA Received Date: 01/16/2020; 04/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Date Report Sent to FDA: 01/01/2005