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

Catalog Number	400SMTHXSFT2H08
Medical Device Problem Codes	Material Frayed (1262); Retraction Problem (1536); Stretched (1601); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/09/2017
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils).During the procedure, the physician advanced a smart coil into the patient using a non-penumbra microcatheter but decided to remove the coil and use a smaller sized coil.While retracting the smart coil back through microcatheter, the physician encountered slight resistance.Upon removal, the physician noticed that the smart coil was frayed and slightly stretched.Therefore, the procedure was completed using new smart coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The penumbra smart coil (smart coil) was received tightly wound around itself.The embolization coil was damaged throughout its length.The pusher assembly was kinked and bent along its length.During functional analysis, the introducer sheath was back loaded onto the smart coil pusher assembly but the embolization coil was unable to be advanced out of the introducer sheath.Evaluation of the returned smart coil revealed that the embolization coil had offset coil winds along its length and was stretched.If an attempt is made to retract the embolization coil against resistance, this type of damage can occur.Further evaluation revealed the pusher assembly was kinked and bent along its length.These damages were likely incidental and occurred during packaging for return to penumbra.The non-penumbra microcatheter mentioned in the complaint was not returned for evaluation.As a result, the root cause of the initial resistance could not be determined.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.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6846816
• Report Number: 3005168196-2017-01469
• Device Sequence Number: 1430168
• Product Code: HCG
• UDI-Device Identifier: 00814548016016
• UDI-Public: 00814548016016
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/09/2017

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: Physician
• Device Expiration Date: 12/14/2021
• Device Catalogue Number: 400SMTHXSFT2H08
• Device Lot Number: F73169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Initial Date Received by Manufacturer: 08/09/2017
• Supplement Date Received by Manufacturer: 09/19/2017
• Initial Report FDA Received Date: 09/06/2017
• Supplement Report FDA Received Date: 10/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1