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

Catalog Number	400SMTHXSFT0410
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/05/2018
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: 3005168196-2018-01561; 3005168196-2018-01563; 3005168196-2018-01564.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (a-comm) using penumbra smart coils (smart coils) and a penumbra smart coil detachment handle (handle).It was noted that the patient's anatomy was tortuous.During the procedure, the physician deployed and detached three smart coils in the target vessel using a non-penumbra microcatheter.The physician then was unable to detach another smart coil using the handle; therefore, the smart coil was removed.Next, the physician advanced another smart coil through the microcatheter; however, while retracting to re-position the smart coil within the microcatheter, the smart coil unintentionally detached inside the microcatheter.Therefore, the physician removed the microcatheter containing the detached smart coil from the patient.Later in the procedure, while attempting to advance a new smart coil through the microcatheter, the physician experienced resistance and was unable to advance the smart coil; therefore, it was removed.The procedure was completed using six smart coils, other 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 in multiple locations.The embolization coil was intact with its pusher assembly and had offset coil winds.Conclusions: evaluation of the first smart coil revealed the pet lock was intact on the proximal end of the pusher assembly.If the pet lock is broken it typically indicates a pull force was applied to the proximal end in attempt to detach the embolization coil.As the pet lock was not broken it¿s possible the detachment handle was not properly attached to the proximal end of the pusher assembly when attempting to detach the coil.Further evaluation revealed offset coils winds and kinks on both the pusher assembly and introducer sheath.These damages may have been due to forceful manipulation during the procedure or were incidental and occurred during packaging for return to penumbra.Evaluation of the second smart coil revealed the embolization coil was intact with the pusher assembly and the pet lock was intact.The reported complaint of unintentional detachment could not be confirmed.Further evaluation revealed pusher assembly kinks and offset coil winds.These damages may have been due to forceful manipulation during the procedure or were incidental and occurred during packaging for return to penumbra.Evaluation of the third smart coil revealed a kinked pusher assembly and offset coil winds.If the introducer sheath is not properly aligned within the hub of the microcatheter prior to advancement may cause resistance.If the smart coil is subsequently advanced against this resistance the embolization coil winds will likely become offset.Further evaluation revealed a kinked pusher assembly.These kinks were likely due to forceful advancement against the experienced resistance.Some of these kinks may have been incidental and may have occurred during packaging for return to penumbra.Penumbra coils are visually 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: 7779302
• Report Number: 3005168196-2018-01562
• Device Sequence Number: 1084709
• Product Code: HCG
• UDI-Device Identifier: 00814548015835
• UDI-Public: 00814548015835
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2018
• 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: 12/07/2022
• Device Catalogue Number: 400SMTHXSFT0410
• Device Lot Number: F80929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/17/2018
• Supplement Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 08/13/2018
• Supplement Report FDA Received Date: 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Date Report Sent to FDA: 01/01/2005