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

Catalog Number	400SMTXSFT0203
Medical Device Problem Codes	Physical Resistance (2578); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/20/2017
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 number: 3005168196-2017-00775.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a spinal tumor using penumbra smart coils (smart coils).During the procedure, while attempting to advance two smart coils through a non-penumbra microcatheter, the physician experienced resistance; therefore, the smart coils were removed.The procedure was successfully completed using additional smart coils and the same microcatheter.It was reported that the smart coils seemed to be buckling on themselves.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 the embolization coil windings were offset on the proximal end of the coil.Conclusions: evaluation of the first and second smart coils revealed that both embolization coil windings were offset.This type of damage typically occurs due to improper handling during use.If the introducer sheath is not properly seated in the hub of the microcatheter prior to advancement, damage such as this may occur.During the functional analysis both smart coils could not be advanced through demonstration microcatheter.The offset coil windings likely contributed to the resistance experienced during advancement.Further evaluation of the both smart coils also revealed that the pusher assemblies were kinked.These kinks were likely incidental and may have occurred while packaging the devices for returned.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.This report is associated with mfr report number: 3005168196-2017-00775.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6576618
• Report Number: 3005168196-2017-00774
• Device Sequence Number: 699026
• Product Code: HCG
• UDI-Device Identifier: 00814548015279
• UDI-Public: 00814548015279
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 04/21/2017

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: 02/09/2021
• Device Catalogue Number: 400SMTXSFT0203
• Device Lot Number: F67867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2017
• Initial Date Received by Manufacturer: 04/21/2017
• Supplement Date Received by Manufacturer: 06/08/2017
• Initial Report FDA Received Date: 05/18/2017
• Supplement Report FDA Received Date: 07/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1