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

Catalog Number	400SMTSFT0615
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	09/16/2019
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.This report is associated with mfr report number: 3005168196-2019-01922.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils).During the procedure, the physician encountered resistance while advancing a 6x15 smart coil into the non-penumbra microcatheter.The physician also reported that the 6x15 smart coil stopped advancing at the middle of the microcatheter.The 6x15 smart coil was therefore removed from the procedure.A new 6x15 smart coil was then implanted successfully using the same microcatheter.While advancing the next 4x6 smart coil through its introducer sheath, the physician encountered resistance and reported that it became stuck and would no longer advance.The 4x6 smart coil was therefore removed and was no longer used in the procedure.Another smart coil and the same microcatheter were then used to complete the procedure.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Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly mid-joint was retracted through the introducer sheath friction lock.The embolization coil was undamaged and intact with its pusher assembly.Conclusions: evaluation of the first returned smart coil revealed a functional device.Further evaluation revealed the pusher assembly mid-joint was retracted through its introducer sheath friction lock.If this occurs, resistance may be experienced during advancement of the smart coil within its introducer sheath.This damage was likely incidental to the reported complaint and may have occurred after removal of the device from the procedure.During functional testing, the smart coil was advance through its introducer sheath and a demonstration microcatheter with resistance while advancing the pusher assembly mid-joint through the introducer sheath friction lock.The non-penumbra microcatheter identified in the complaint was not returned for evaluation; therefore, the root cause of the inability to advance the smart coil during the procedure could not be determined.Evaluation of the second returned smart coil revealed the pusher assembly mid-joint was retracted through the introducer sheath friction lock and the pusher assembly kinks.If this occurs, resistance may be experienced during advancement of the smart coil through its introducer sheath.Forcefully advancement against resistance may result in the pusher assembly kinks.During functional testing, resistance was experienced while attempting to advance the pusher assembly mid-joint through the introducer sheath friction lock; therefore, the introducer sheath was removed distally, and the smart coil was re-sheathed properly.The smart coil was then advanced through its introducer sheath and a demonstration microcatheter with resistance due to the pusher assembly kinks.Further evaluation revealed additional pusher assembly kinks.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.This report is associated with mfr report number: 3005168196-2019-01922 h3 other text : placeholder.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9195032
• Report Number: 3005168196-2019-01923
• Device Sequence Number: 11703067
• Product Code: HCG
• UDI-Device Identifier: 00814548014975
• UDI-Public: 00814548014975
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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): 09/16/2019
• 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: 10/02/2023
• Device Catalogue Number: 400SMTSFT0615
• Device Lot Number: F86219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/16/2019
• Supplement Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Date Report Sent to FDA: 01/01/2005