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

Catalog Number	400SMTXSFT011H
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the fourth evaluated smart coil pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 120.0 cm from the proximal end.The embolization coil was intact with its pusher assembly and had offset coil winds.Conclusions: evaluation of the first and fourth smart coils revealed that the embolization coil had offset coil winds.If the introducer sheath is not properly aligned within the hub of the microcatheter prior to advancement, damage such as this may occur.During the functional test resistance was encountered, while attempting to advance the smart coil through of its introducer sheath and was unable to be advanced any further.Evaluation of the second and third smart coils revealed that the embolization coil winds were offset.If the introducer sheath is not properly aligned within the hub of the microcatheter prior to advancement through the microcatheter, damage such as this may occur.During the functional test, both embolization coils began to take shape inside the hub of the demonstration microcatheter and could not be advanced any further.If the offset coil are present prior to the functional test during evaluation, it is likely that the embolization coil may take shape inside the hub of a demonstration microcatheter.All four returned smart coils pusher assemblies had kinks.These kinks were likely incidental to the reported issue and may have occurred while attempting to advance the coils against resistance and packaging the devices backwards inside there packaging hoops.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils).During the procedure, the physician was unable to advance four smart coils into the hub of the non-penumbra microcatheter and, therefore, the smart coils were removed.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda 94502
• MDR Report Key: 7679262
• Report Number: 3005168196-2018-01360
• Device Sequence Number: 1384159
• Product Code: HCG
• UDI-Device Identifier: 00814548015170
• UDI-Public: 00814548015170
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 06/11/2018

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: 04/09/2022
• Device Catalogue Number: 400SMTXSFT011H
• Device Lot Number: F75504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2018
• Initial Report FDA Received Date: 07/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1