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

Catalog Number	400SMTHXSFT2H08
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the penumbra smart coil (smart coil) pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.The embolization coil had several offset coil winds and was bunched inside the introducer sheath.During functional analysis, the embolization coil was initially unable to be advanced out of the introducer sheath.After flushing the coil and sheath, the device was able to be advanced out of the introducer sheath with resistance but was unable to be advanced into a demonstration microcatheter.Conclusions: evaluation of the returned smart coil revealed a damage embolization coil, which was unable to be advanced into a demonstration catheter.The embolization coil had several offset coil winds.If the introducer sheath is not properly aligned within the hub prior to advancement, offset coil winds may result.These offset coil winds will likely cause resistance and contribute to the inability to advance the embolization coil into the microcatheter.Further evaluation revealed the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.The friction lock inner diameter (id) is smaller than the rest of the introducer sheath, which allows the introducer sheath to properly seat on the pusher assembly mid-joint.If the pusher assembly mid-joint is forcefully withdrawn beyond the introducer sheath friction lock, it is likely that resistance will be experienced upon attempting to advance the coil.The non-penumbra microcatheter mentioned in the complaint was not returned for evaluation.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils).During the procedure, the physician experienced difficulty advancing a smart coil out of its introducer sheath and into the non-penumbra microcatheter.Therefore, the smart coil was removed and the procedure was completed using a new smart coil, additional coils and the same microcatheter.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 CA 94502
• MDR Report Key: 7119524
• Report Number: 3005168196-2017-02224
• Device Sequence Number: 13902989
• Product Code: HCG
• UDI-Device Identifier: 00814548016016
• UDI-Public: 00814548016016
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 11/20/2017

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: 12/26/2021
• Device Catalogue Number: 400SMTHXSFT2H08
• Device Lot Number: F73353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2017
• Initial Report FDA Received Date: 12/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR