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

Model Number	400SMTHXSFT0103
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/04/2020
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.This report is associated with mfr report number: 3005168196-2020-01300.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the lumbar artery using penumbra smart coils (smart coils), ruby coils and a non-penumbra microcatheters.It was noted that the patient anatomy was tortuous and calcified.During the procedure, the physician placed three smart coils into the target location using the microcatheter.While advancing another smart coil into the hub of the microcatheter, the physician experienced resistance.The physician then removed the smart coil and checked it on the back table by advancing the smart coil within its introducer sheath and subsequently, the physician experienced resistance.Therefore, the smart coil was not used for the remainder of the procedure.Next, the physician placed two smart coils into the target location using the microcatheter.Then, while advancing another smart coil into the hub of the microcatheter, the physician experienced resistance; therefore, the smart coil was removed.The procedure was completed using seven smart coils, four ruby coils and the same microcatheters.There was no report of an adverse effect to this patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 14.5, 61.0, 98.0, 132.5, 134.0, 137.0 and 138.5 cm from the proximal end.The pusher assembly mid-joint was retracted into the introducer sheath friction lock.The embolization coil was intact with the pusher assembly and had offset coil winds.Conclusions: evaluation of the first returned smart coil revealed offset coil winds along the embolization coil.If the introducer sheath is not aligned properly within the hub of a parent device, the embolization coil may begin to take shape within the hub and resistance may be experienced and damage such as offset coil winds may occur.Further evaluation revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock and pusher assembly kinks.If the pusher assembly mid-joint is retracted through the introducer sheath friction lock, resistance may be experienced and damage such as pusher assembly kinks may occur.This damage may have occurred during handling after removal from the procedure.During functional testing, the smart coil was unable to advance through the hub of a demonstration microcatheter due to resistance cause by the offset coil winds.Evaluation of the second returned smart coil revealed offset coil winds along the embolization coil.If the introducer sheath is not aligned properly within the hub of a parent device, the embolization coil may begin to take shape within the hub and resistance may be experienced and damage such as offset coil winds may occur.Further evaluation revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock and pusher assembly kinks.If the pusher assembly mid-joint is retracted through the introducer sheath friction lock, resistance may be experienced and damage such as pusher assembly kinks may occur.This damage may have occurred during handling after removal from the procedure.During functional testing, the smart coil was able to advance from its returned position within the introducer sheath with resistance due to the offset coil winds; however, the smart coil was unable to advance out of its introducer sheath due to the pusher assembly kink.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: 3005168196-2020-01300.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10462770
• Report Number: 3005168196-2020-01299
• Device Sequence Number: 13990025
• Product Code: HCG
• UDI-Device Identifier: 00814548015620
• UDI-Public: 00814548015620
• 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): 08/04/2020
• 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: 10/14/2023
• Device Model Number: 400SMTHXSFT0103
• Device Catalogue Number: 400SMTHXSFT0103
• Device Lot Number: F86450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005