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

Catalog Number	400SMTHXSFT0101
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	05/23/2019
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.This report is associated with mfr report numbers: 3005168196-2019-01213, 3005168196-2019-01214.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right posterior communicating artery (pcom) using penumbra smart coils (smart coils).During the procedure, while attempting to advance a smart coil into a non-penumbra microcatheter, the physician experienced extreme resistance and the smart coil would not advance out of its introducer sheath; therefore, it was removed.The physician attempted to advance a new smart coil, but the same issue occurred and, therefore, it was removed.The physician experienced resistance while attempting to advance a third smart coil; however, the physician continued to push very hard and reported that he felt it ¿popped¿ forward and the smart coil was successfully placed in the target vessel and completed the procedure.There was no adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The smart coil pusher assembly mid-joint was proximal to the introducer sheath friction lock.The embolization coil was intact with the pusher assembly and undamaged.The pusher assembly mid-joint was tested with fx-7487 ring gauge and within specification.Conclusions: evaluation of the returned first smart coil revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If the mid-joint is retracted proximal to the friction lock, resistance will likely be experienced during advancing the device.During functional testing, resistance was encountered while advancing the device.After pusher assembly mid-joint was passed through the introducer sheath friction lock, the embolization coil was able to advance through its introducer sheath and a demonstration microcatheter without issue.Evaluation of the returned second smart coil revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If the mid-joint is retracted proximal to the friction lock, resistance will likely be experienced during advancing the device.During functional testing, the device was properly re-sheathed within its introducer sheath.After properly re-sheathed, the device was able to advance through its introducer sheath and a demonstration microcatheter without issue.Further investigation revealed a bend on the pusher assembly.This damage may have occurred due to forceful advancement against resistance while attempting to advance the pusher assembly through its introducer sheath.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 numbers: 1.(b)(4).2.(b)(4).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: 8720412
• Report Number: 3005168196-2019-01212
• Device Sequence Number: 2220825
• Product Code: HCG
• UDI-Device Identifier: 00814548015590
• UDI-Public: 00814548015590
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 05/23/2019
• 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: 01/14/2024
• Device Catalogue Number: 400SMTHXSFT0101
• Device Lot Number: F87947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 08/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 59
• Date Report Sent to FDA: 01/01/2005