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

Catalog Number	400SMTSTD0620
Medical Device Problem Codes	Fracture (1260); Difficult or Delayed Activation (2577); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Results: the pet lock was broken on the proximal end of the penumbra smart coil (smart coil) pusher assembly, and the pull wire was fractured.The segment of the pull wire that was fractured was removed from the handle by the penumbra investigator.The pusher assembly was kinked approximately 3.5 cm from the proximal end.The embolization coil was detached from the pusher assembly.Conclusions: evaluation of the returned devices revealed that the handle was functional.The handle was tested using the handle fixture and was found to be within specification.Further evaluation revealed that the smart coil¿s pusher assembly was kinked and the pull wire was fractured.This type of damage typically occurs due to improper handling during use.If the device is forcefully manipulated while attempting to detach the coil, the pusher assembly may become kinked.Furthermore, if the handle is actuated multiple times while the pull wire is inserted through the handle funnel, the pull wire may become pulled into the handle and fracture.The root cause of the handle not detaching the coil on the first attempt could not be determined.Penumbra handles are functionally tested during incoming inspection.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 treating a aural arteriovenous fistula (d-avf) using penumbra smart coils (smart coils) and a penumbra smart coil detachment handle (handle).During the procedure, the physician deployed and detached two non-penumbra coils in the target vessel using a non-penumbra microcatheter before deploying and detaching a smart coil in the target vessel using the handle.Next, the physician deployed a new smart coil in the target vessel; however, upon attempting to detach the smart coil using the handle, it failed to detach.The physician then attempted to detach this smart coil again using the same handle and it successfully detached and was implanted in the target vessel.However, the proximal portion of the smart coil pusher assembly became fractured and was stuck in the handle.Therefore, the pusher assembly ans the handle were removed and the physician continued the procedure by placing several non-penumbra coils in the target vessel.Next, the physician deployed and detached a new smart coil in the target vessel using a new handle with no issues.The procedure ended at that point and 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: 5919538
• Report Number: 3005168196-2016-01250
• Device Sequence Number: 723956
• Product Code: HCG
• UDI-Device Identifier: 00814548014678
• UDI-Public: 00814548014678
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/01/2016

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: 04/18/2021
• Device Catalogue Number: 400SMTSTD0620
• Device Lot Number: F68974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2016
• Initial Report FDA Received Date: 08/31/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR